Cumulative Risk Assessment; Science Advisory Committee on Chemicals (SACC) Virtual Public Meeting; Notice of Availability and Request for Comment, 12354-12356 [2023-03974]
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12354
Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices
including the requirements for PEP. PEP
is authorized under section 484(t) of the
Higher Education Act of 1965, as
amended (HEA) with the requirements
for participation outlined in 34 CFR
668, Subpart P, effective July 1, 2023.
These are new regulatory requirements
that are required for a school to offer a
PEP to confined or incarcerated
individuals. This is a request for a new
information collection to collect on the
proposed form the information needed
for institutions to apply to participate in
PEP.
Dated: February 21, 2023.
Kun Mullan,
PRA Coordinator, Strategic Collections and
Clearance, Governance and Strategy Division,
Office of Chief Data Officer, Office of
Planning, Evaluation and Policy
Development.
[FR Doc. 2023–03922 Filed 2–24–23; 8:45 am]
BILLING CODE 4000–01–P
em.doe.gov or telephone: (702) 918–
6715.
SUPPLEMENTARY INFORMATION:
Purpose of the Board: The purpose of
the Board is to make recommendations
to DOE–EM and site management in the
areas of environmental restoration,
waste management, and related
activities.
Tentative Agenda Topics
•
•
•
•
EM Update
Chairs Round Robin
Public Comment
Budget Update and Simulation
Exercise
Minority Serving Institutions
Partnership Program
Community Capacity Building
Membership On-Boarding
Board Business/Open Discussion
Wednesday, March 22, 2023
•
•
•
•
•
DEPARTMENT OF ENERGY
Environmental Management SiteSpecific Advisory Board Chairs
Office of Environmental
Management, Department of Energy.
ACTION: Notice of open meeting.
AGENCY:
This notice announces an inperson/virtual hybrid meeting of the
Environmental Management SiteSpecific Advisory Board (EM SSAB)
Chairs. The Federal Advisory
Committee Act requires that public
notice of this meeting be announced in
the Federal Register.
DATES: Tuesday, March 21, 2023; 9
a.m.–5 p.m. EDT
Wednesday, March 22, 2023; 1:30
p.m.–5 p.m. EDT
ADDRESSES: This hybrid meeting will be
open to the public virtually (observation
only). To obtain a copy of the virtual
link, please contact Kelly Snyder by
email, kelly.snyder@em.doe.gov, no later
than 4:00 p.m. EDT on Tuesday, March
14, 2023.
For EM SSAB Chairs, Vice-Chairs and
staff, the meeting will be held, strictly
following COVID–19 precautionary
measures, at: U.S. Department of
Energy, 1000 Independence Avenue
SW, Room 6E–069, Washington, DC
20585.
Attendees should check the EM SSAB
website (https://www.energy.gov/em/
em-site-specific-advisory-board) for any
meeting format changes due to COVID–
19 protocols.
FOR FURTHER INFORMATION CONTACT:
Kelly Snyder, EM SSAB Designated
Federal Officer, Email: kelly.snyder@
ddrumheller on DSK120RN23PROD with NOTICES
SUMMARY:
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EM’s International Program Overview
EM’s National Laboratory Network
Technology Development Overview
Public Comment
Board Business/Open Discussion
Public Participation: As a COVID–19
precaution, the meeting will be open to
the public virtually only. To obtain a
copy of the virtual link, send an email
to Kelly Snyder at kelly.snyder@
em.doe.gov no later than 4:00 p.m. ET
on Tuesday, March 14, 2023. The EM
SSAB welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please note this when
registering. Public comments will be
accepted via email for virtual
participants prior to and after the
meeting. Comments received in writing
no later than 4:00 p.m. EDT on Tuesday,
March 14, 2023, will be read aloud
during the meeting. Comments will also
be accepted after the meeting by no later
than 4:00 p.m. EDT on Tuesday, March
28, 2023, to be included in the official
meeting record. Please send comments
to Kelly Snyder at Kelly.snyder@
em.doe.gov. Please put ‘‘Public
Comment’’ in the subject line. The
Designated Federal Officer is
empowered to conduct the meeting in a
fashion that will facilitate the orderly
conduct of business. Individuals
wishing to submit public comments
should follow as directed above.
Minutes: Minutes will also be
available at the following website:
https://energy.gov/em/listings/chairsmeetings.
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[FR Doc. 2023–03968 Filed 2–24–23; 8:45 am]
BILLING CODE 6450–01–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2022–0918; FRL–10490–
02–OCSPP]
Tuesday, March 21, 2023
•
•
•
•
Signed in Washington, DC, on February 22,
2023.
LaTanya Butler,
Deputy Committee Management Officer.
Cumulative Risk Assessment; Science
Advisory Committee on Chemicals
(SACC) Virtual Public Meeting; Notice
of Availability and Request for
Comment
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Environmental Protection
Agency (EPA) is announcing the
availability of and soliciting public
comment on two draft documents that
are being submitted to the Science
Advisory Committee on Chemicals
(SACC) for peer review: ‘‘Draft Proposed
Principles of Cumulative Risk
Assessment under the Toxic Substances
Control Act’’ and ‘‘Draft Proposed
Approach for Cumulative Risk
Assessment of High-Priority Phthalates
and a Manufacturer-Requested Phthalate
under the Toxic Substance Control
Act.’’ The SACC will consider and
review these documents at a 4-day
virtual public meeting on May 8 to 11,
2023, that was previously announced in
the Federal Register of December 21,
2022.
SUMMARY:
The following is a chronological
listing of the dates for the specific
activities that are described in more
detail under SUPPLEMENTARY
INFORMATION.
April 24, 2023—Deadline for
submitting a request for special
accommodations for participating in the
virtual public meeting in order to allow
EPA time to process the request before
the meeting.
April 28, 2023—Deadline for
providing comments for distribution to
the SACC before the meeting.
May 1, 2023—Deadline for registering
to be listed on the meeting agenda to
make oral comments during the virtual
meeting. Those not making oral
comments may continue to register
through May 11, 2023 in order to
receive the links to observe the meeting.
ADDRESSES: Submit written comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2022–0918,
through the Federal eRulemaking Portal
DATES:
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Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices
at https://www.regulations.gov. Follow
the online instructions for submitting
comments. Do not electronically submit
any information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Copyrighted
material will not be posted without
explicit permission from the copyright
holder. Members of the public should
also be aware that personal information
included in any written comments may
be posted on the internet at https://
www.regulations.gov. Additional
information on commenting or visiting
the docket, along with more information
about dockets generally, is available at
https://www.epa.gov/dockets.
For information on how to register
and access the virtual public meeting,
please refer to the SACC website at
https://www.epa.gov/tsca-peer-review.
EPA intends to announce registration
instructions on the SACC website by
early April 2023. You may also
subscribe to the following listserv for
alerts regarding this and other SACCrelated activities: https://
public.govdelivery.com/accounts/
USAEPAOPPT/subscriber/new?topic_
id=USAEPAOPPT_101.
For information on special
accommodations, meeting access or
services for individuals with
disabilities, and to request
accommodation for a disability, please
contact the Designated Federal Officer
(DFO) listed under FOR FURTHER
INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT:
Contact the DFO, Dr. Alaa Kamel,
Mission Support Division (7602M),
Office of Program Support, Office of
Chemical Safety and Pollution
Prevention, EPA, telephone number:
(202) 564–5336 or call the SACC main
office at (202) 564–8450; email address:
kamel.alaa@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
ddrumheller on DSK120RN23PROD with NOTICES
A. Does this action apply to me?
This action is directed to the public
in general.
B. What action is the Agency taking?
EPA is announcing the availability of
and soliciting public comment on the
following two draft documents that are
being submitted to the Science Advisory
Committee on Chemicals (SACC) for
peer review: ‘‘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 ManufacturerRequested Phthalate under the Toxic
VerDate Sep<11>2014
20:06 Feb 24, 2023
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Substance Control Act.’’ The SACC will
consider and review these documents at
a 4-day virtual public meeting on May
8 to 11, 2023, which was previously
announced in the Federal Register of
December 21, 2022 (87 FR 78103 (FRL–
10490–01–OCSPP)).
This document provides instructions
for accessing the materials provided to
the SACC, submitting comments, and
registering to provide oral comments at
the meeting.
C. What is the Agency’s authority for
taking this action?
The SACC was established by EPA in
2016 in accordance with the Toxic
Substances Control Act (TSCA), 15
U.S.C. 2625(o), as amended by the Frank
R. Lautenberg Chemical Safety for the
21st Century Act, Public Law 114–182,
June 22, 2016, to provide independent
advice and expert consultation, at the
request of the Administrator, with
respect to the scientific and technical
aspects of issues relating to the
implementation of TSCA. The SACC
operates in accordance with the Federal
Advisory Committee Act (FACA), 5
U.S.C. 10 et seq., and supports activities
under the TSCA, 15 U.S.C. 2601 et seq.,
the Pollution Prevention Act (PPA), 42
U.S.C. 13101 et seq., and other
applicable statutes.
D. What should I consider as I submit
my comments to EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email (contact the
DFO listed under FOR FURTHER
INFORMATION CONTACT for instructions).
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 comments.
When preparing and submitting your
comments, see Tips for Effective
Comments at https://www.epa.gov/
dockets.
II. Background
A. What is the purpose of the SACC?
The SACC provides independent
scientific advice and recommendations
to the EPA on the scientific and
technical aspects of risk assessments,
methodologies, and pollution
prevention measures and approaches for
chemicals regulated under TSCA. The
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12355
SACC is composed of experts in
toxicology; environmental risk
assessment; exposure assessment; and
related sciences (e.g., synthetic biology,
pharmacology, biotechnology,
nanotechnology, biochemistry,
biostatistics, physiologically based
pharmacokinetic modeling (PBPK),
computational toxicology,
epidemiology, environmental fate, and
environmental engineering and
sustainability). The SACC currently
consists of 17 members. When needed,
the committee will be assisted by ad hoc
peer reviewers with specific expertise in
the topics under consideration.
B. Why did EPA develop these
documents?
Between 2020 and 2022, EPA
published final scoping documents for
20 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)].
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.
EPA’s document entitled ‘‘Draft
Proposed Principles of Cumulative Risk
Assessment under the Toxic Substances
Control Act’’ describes 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, a
copy of which is being submitted to the
SACC for review and is available in the
docket for public review, is not a
framework nor a guidance document on
conducting CRAs of chemical
substances, and it does not address
cumulative impacts.
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
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Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices
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’’ (a
copy can be accessed at 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 ManufacturerRequested Phthalate under the Toxic
Substance Control Act’’ describes 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 follows many
of the recommendations made by the
NRC in 2008. This draft document, a
copy of which is being submitted to the
SACC for review and is available in the
docket for public review, is not a CRA,
and no risk estimates are presented.
Instead, this draft document outlines
several options EPA is considering for
conducting a phthalate CRA under
TSCA.
In submitting these two draft
documents to the SACC for peer review,
EPA is soliciting comments from the
SACC on issues related to chemical
grouping for purposes of 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.
ddrumheller on DSK120RN23PROD with NOTICES
III. Virtual Public Meeting
A. What is the purpose of this public
meeting of the SACC?
The focus of the 4-day virtual public
meeting is the SACC peer review of the
following two draft documents and
related public comments received by the
deadlines listed under the DATES
section:
• 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-
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20:06 Feb 24, 2023
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Requested Phthalate under the Toxic
Substance Control Act.
EPA will 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.
B. How can I access the documents
submitted for review to the SACC?
These documents, including
background documents, related
supporting materials, and draft charge
questions provided to the SACC, are
available in the docket. As additional
background materials become available
and are provided to the SACC, EPA will
include those additional background
documents in the docket. All of these
documents will be available through
https://www.regulations.gov in Docket
ID No. EPA–HQ–OPPT–2022–0918 and
links on the SACC website at https://
www.epa.gov/tsca-peer-review.
After the public meeting, the SACC
will prepare a meeting minutes and
final report document summarizing its
recommendations to the EPA. This
document will also be added to the
docket and available through the SACC
website.
C. How can I provide comments for the
SACC’s consideration?
To ensure proper receipt of comments
by EPA, it is imperative that you
identify Docket ID No. EPA–HQ–OPPT–
2022–0918 in the subject line on the
first page of your comments and follow
the instructions in this unit.
1. Written comments. Written
comments must be submitted by the
deadlines set in the DATES section and
following the instructions in this
document.
2. Oral comments. Each individual or
group wishing to make brief oral
comments to the SACC during the peer
review virtual public meeting must
register to do so by the deadline set in
the DATES section and following the
registration instructions that will be
announced on the SACC website by
early April 2023. Oral comments will be
limited to 5 minutes. In addition, each
speaker should submit a copy of their
comments to the DFO prior to the
meeting for distribution to the SACC by
the DFO and inclusion in the docket.
D. How can I participate in the virtual
public meeting?
The virtual public 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
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follow the registration instructions that
will be announced on the SACC website
in April.
Authority: 15 U.S.C. 2625(o); 5 U.S.C
10 et. seq.
Dated: February 22, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2023–03974 Filed 2–24–23; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9542–03–OAR]
Allocations of Cross-State Air
Pollution Rule Allowances From New
Unit Set-Asides for 2022 Control
Periods
Environmental Protection
Agency (EPA).
ACTION: Notice of data availability.
AGENCY:
The Environmental Protection
Agency (EPA) is providing notice of the
availability of data on emission
allowance allocations to certain units
under the Cross-State Air Pollution Rule
(CSAPR) trading programs. EPA has
completed preliminary calculations for
the allocations of allowances from the
CSAPR new unit set-asides (NUSAs) for
the 2022 control periods and has posted
spreadsheets containing the calculations
on EPA’s website. EPA will consider
timely objections to the preliminary
calculations (including objections
concerning the identification of units
eligible for allocations) before
determining the final amounts of the
allocations.
SUMMARY:
Objections to the information
referenced in this notice must be
received on or before March 29, 2023.
ADDRESSES: Submit your objections via
email to CSAPR@epa.gov. Include
‘‘2022 NUSA allocations’’ in the email
subject line and include your name,
title, affiliation, address, phone number,
and email address in the body of the
email.
DATES:
FOR FURTHER INFORMATION CONTACT:
Questions concerning this action should
be addressed to Jason Kuhns at (202)
564–3236 or kuhns.jason@epa.gov or
Andrew Reighart at (202) 564–0418 or
reighart.andrew@epa.gov.
SUPPLEMENTARY INFORMATION: Under
each CSAPR trading program where
EPA is responsible for determining
emission allowance allocations, a
portion of each state’s emissions budget
for the program for each control period
is reserved in a NUSA (and in an
E:\FR\FM\27FEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12354-12356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03974]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2022-0918; FRL-10490-02-OCSPP]
Cumulative Risk Assessment; Science Advisory Committee on
Chemicals (SACC) Virtual Public Meeting; Notice of Availability and
Request for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and soliciting public comment on two draft documents
that are being submitted to the Science Advisory Committee on Chemicals
(SACC) for peer review: ``Draft Proposed Principles of Cumulative Risk
Assessment under the Toxic Substances Control Act'' and ``Draft
Proposed Approach for Cumulative Risk Assessment of High-Priority
Phthalates and a Manufacturer-Requested Phthalate under the Toxic
Substance Control Act.'' The SACC will consider and review these
documents at a 4-day virtual public meeting on May 8 to 11, 2023, that
was previously announced in the Federal Register of December 21, 2022.
DATES: The following is a chronological listing of the dates for the
specific activities that are described in more detail under
SUPPLEMENTARY INFORMATION.
April 24, 2023--Deadline for submitting a request for special
accommodations for participating in the virtual public meeting in order
to allow EPA time to process the request before the meeting.
April 28, 2023--Deadline for providing comments for distribution to
the SACC before the meeting.
May 1, 2023--Deadline for registering to be listed on the meeting
agenda to make oral comments during the virtual meeting. Those not
making oral comments may continue to register through May 11, 2023 in
order to receive the links to observe the meeting.
ADDRESSES: Submit written comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2022-0918, through the Federal eRulemaking
Portal
[[Page 12355]]
at https://www.regulations.gov. Follow the online instructions for
submitting comments. Do not electronically submit any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Copyrighted
material will not be posted without explicit permission from the
copyright holder. Members of the public should also be aware that
personal information included in any written comments may be posted on
the internet at https://www.regulations.gov. Additional information on
commenting or visiting the docket, along with more information about
dockets generally, is available at https://www.epa.gov/dockets.
For information on how to register and access the virtual public
meeting, please refer to the SACC website at https://www.epa.gov/tsca-peer-review. EPA intends to announce registration instructions on the
SACC website by early April 2023. 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.
For information on special accommodations, meeting access or
services for individuals with disabilities, and to request
accommodation for a disability, please contact the Designated Federal
Officer (DFO) listed under FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: Contact the DFO, Dr. Alaa Kamel,
Mission Support Division (7602M), Office of Program Support, Office of
Chemical Safety and Pollution Prevention, EPA, telephone number: (202)
564-5336 or call the SACC main office at (202) 564-8450; 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.
B. What action is the Agency taking?
EPA is announcing the availability of and soliciting public comment
on the following two draft documents that are being submitted to the
Science Advisory Committee on Chemicals (SACC) for peer review: ``Draft
Proposed Principles of Cumulative Risk Assessment under the Toxic
Substances Control Act'' and ``Draft Proposed Approach for Cumulative
Risk Assessment of High-Priority Phthalates and a Manufacturer-
Requested Phthalate under the Toxic Substance Control Act.'' The SACC
will consider and review these documents at a 4-day virtual public
meeting on May 8 to 11, 2023, which was previously announced in the
Federal Register of December 21, 2022 (87 FR 78103 (FRL-10490-01-
OCSPP)).
This document provides instructions for accessing the materials
provided to the SACC, submitting comments, and registering to provide
oral comments at the meeting.
C. What is the Agency's authority for taking this action?
The SACC was established by EPA in 2016 in accordance with the
Toxic Substances Control Act (TSCA), 15 U.S.C. 2625(o), as amended by
the Frank R. Lautenberg Chemical Safety for the 21st Century Act,
Public Law 114-182, June 22, 2016, to provide independent advice and
expert consultation, at the request of the Administrator, with respect
to the scientific and technical aspects of issues relating to the
implementation of TSCA. The SACC operates in accordance with the
Federal Advisory Committee Act (FACA), 5 U.S.C. 10 et seq., and
supports activities under the TSCA, 15 U.S.C. 2601 et seq., the
Pollution Prevention Act (PPA), 42 U.S.C. 13101 et seq., and other
applicable statutes.
D. What should I consider as I submit my comments to EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email (contact the DFO listed under FOR FURTHER
INFORMATION CONTACT for instructions). 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 comments. When preparing and submitting your
comments, see Tips for Effective Comments at https://www.epa.gov/dockets.
II. Background
A. What is the purpose of the SACC?
The SACC provides independent scientific advice and recommendations
to the EPA on the scientific and technical aspects of risk assessments,
methodologies, and pollution prevention measures and approaches for
chemicals regulated under TSCA. The SACC is composed of experts in
toxicology; environmental risk assessment; exposure assessment; and
related sciences (e.g., synthetic biology, pharmacology, biotechnology,
nanotechnology, biochemistry, biostatistics, physiologically based
pharmacokinetic modeling (PBPK), computational toxicology,
epidemiology, environmental fate, and environmental engineering and
sustainability). The SACC currently consists of 17 members. When
needed, the committee will be assisted by ad hoc peer reviewers with
specific expertise in the topics under consideration.
B. Why did EPA develop these documents?
Between 2020 and 2022, EPA published final scoping documents for 20
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)]. 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.
EPA's document entitled ``Draft Proposed Principles of Cumulative
Risk Assessment under the Toxic Substances Control Act'' describes 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, a copy of which is
being submitted to the SACC for review and is available in the docket
for public review, is not a framework nor a guidance document on
conducting CRAs of chemical substances, and it does not address
cumulative impacts.
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
[[Page 12356]]
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'' (a copy
can be accessed at 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 High-Priority Phthalates and
a Manufacturer-Requested Phthalate under the Toxic Substance Control
Act'' describes 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 follows many of the recommendations made by the NRC
in 2008. This draft document, a copy of which is being submitted to the
SACC for review and is available in the docket for public review, is
not a CRA, and no risk estimates are presented. Instead, this draft
document outlines several options EPA is considering for conducting a
phthalate CRA under TSCA.
In submitting these two draft documents to the SACC for peer
review, EPA is soliciting comments from the SACC on issues related to
chemical grouping for purposes of CRA, health outcomes related to
phthalate syndrome, and possible approaches to developing the
cumulative hazard and exposure assessment for High-Priority phthalates
and a Manufacturer-Requested phthalate.
III. Virtual Public Meeting
A. What is the purpose of this public meeting of the SACC?
The focus of the 4-day virtual public meeting is the SACC peer
review of the following two draft documents and related public comments
received by the deadlines listed under the DATES section:
Draft Proposed Principles of Cumulative Risk Assessment
under the Toxic Substances Control Act; and
Draft Proposed Approach for Cumulative Risk Assessment of
High-Priority Phthalates and a Manufacturer-Requested Phthalate under
the Toxic Substance Control Act.
EPA will 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.
B. How can I access the documents submitted for review to the SACC?
These documents, including background documents, related supporting
materials, and draft charge questions provided to the SACC, are
available in the docket. As additional background materials become
available and are provided to the SACC, EPA will include those
additional background documents in the docket. All of these documents
will be available through https://www.regulations.gov in Docket ID No.
EPA-HQ-OPPT-2022-0918 and links on the SACC website at https://www.epa.gov/tsca-peer-review.
After the public meeting, the SACC will prepare a meeting minutes
and final report document summarizing its recommendations to the EPA.
This document will also be added to the docket and available through
the SACC website.
C. How can I provide comments for the SACC's consideration?
To ensure proper receipt of comments by EPA, it is imperative that
you identify Docket ID No. EPA-HQ-OPPT-2022-0918 in the subject line on
the first page of your comments and follow the instructions in this
unit.
1. Written comments. Written comments must be submitted by the
deadlines set in the DATES section and following the instructions in
this document.
2. Oral comments. Each individual or group wishing to make brief
oral comments to the SACC during the peer review virtual public meeting
must register to do so by the deadline set in the DATES section and
following the registration instructions that will be announced on the
SACC website by early April 2023. Oral comments will be limited to 5
minutes. In addition, each speaker should submit a copy of their
comments to the DFO prior to the meeting for distribution to the SACC
by the DFO and inclusion in the docket.
D. How can I participate in the virtual public meeting?
The virtual public 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 April.
Authority: 15 U.S.C. 2625(o); 5 U.S.C 10 et. seq.
Dated: February 22, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-03974 Filed 2-24-23; 8:45 am]
BILLING CODE 6560-50-P
