Formaldehyde; Draft Risk Evaluation Peer Review by the Science Advisory Committee on Chemicals (SACC); Request for Nominations of ad hoc Expert Reviewers, 88910-88913 [2023-28430]
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Federal Register / Vol. 88, No. 246 / Tuesday, December 26, 2023 / Notices
need for the ACC II regulations under
section 209(b)(1)(B).
With regard to section 209(b)(1)(C),
EPA must grant a waiver request unless
the Agency finds that California’s
standards are not consistent with
section 202(a). EPA has previously
stated that consistency with section
202(a) requires that California’s
standards must be technologically
feasible within the lead time provided,
giving due consideration to costs, and
that California and applicable Federal
test procedures be consistent.12
EPA also maintains a web page that
contains general information on its
review of California waiver and
authorization requests. Included on that
page are links to prior waiver and
authorization Federal Register notices.
The page can be accessed at https://
www.epa.gov/state-and-localtransportation/vehicle-emissionscalifornia-waivers-and-authorizations.
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IV. Procedures for Public Participation
The virtual public hearing will be
held on January 10, 2024. If necessary,
an additional session may be held on
January 11, 2024, to accommodate the
number of testifiers that sign-up to
testify. The hearing will begin at 10:00
a.m. Eastern Time (ET). All hearing
attendees (including those who do not
intend to provide testimony and merely
listen) should register for the public
hearing at: https://www.epa.gov/
regulations-emissions-vehicles-andengines/virtual-public-hearingcalifornias-advanced-clean-car. Those
seeking to register should do so by
January 4, 2024.
If you require the services of a
translator or special accommodations
such as American Sign Language, please
pre-register for the hearing and describe
your needs by January 4, 2024. EPA may
not be able to arrange accommodations
without advance notice.
Please note that any updates made to
any aspect of the hearing will be posted
online at: https://www.epa.gov/
regulations-emissions-vehicles-andengines/virtual-public-hearing12 See, e.g., 81 FR 78149, 78153–54 (‘‘EPA has
previously stated that the determination is limited
to whether those opposed to the waiver have met
their burden of establishing that California’s
standards are technologically infeasible, or that
California’s test procedures impose requirements
inconsistent with the federal test procedure.
Infeasibility would be shown here by demonstrating
that there is inadequate lead time to permit the
development of technology necessary to meet the
2013 HD OBD New or Stricter Requirements that
are subject to the waiver request, giving appropriate
consideration to the cost of compliance within that
time.’’) (citing 38 FR 30136 (November 1, 1973) and
40 FR 30311 (July 18, 1975)); 81 FR 95982, 95986
(December 29, 2016); 70 FR 50322 (August 26,
2005).
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californias-advanced-clean-car. While
EPA expects the hearing to go forward
as set forth above, please monitor the
website or contact the person listed in
the FOR FURTHER INFORMATION CONTACT
section to determine if there are any
updates. EPA does not intend to publish
a document in the Federal Register
announcing updates.
Each commenter will have 3 minutes
to provide oral testimony. EPA may ask
clarifying questions during the oral
presentations but will not respond to
the presentations at that time. EPA
recommends submitting the text of your
oral comments as written comments to
the docket for this action. Written
statements and supporting information
submitted during the comment period
will be considered with the same weight
as oral comments and supporting
information presented at the public
hearing.
The Agency will make a verbatim
record of the proceedings at the hearing
that will be placed in the docket. EPA
will keep the record open until February
27, 2024. After expiration of the
comment period, the Administrator will
render a decision on CARB’s request
based on the record of the public
hearing, relevant written submissions,
and other information that he deems
pertinent.
Sarah Dunham,
Director, Office of Transportation and Air
Quality, Office of Air and Radiation.
[FR Doc. 2023–28301 Filed 12–22–23; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2023–0613; FRL–11608–
01–OCSPP]
Formaldehyde; Draft Risk Evaluation
Peer Review by the Science Advisory
Committee on Chemicals (SACC);
Request for Nominations of ad hoc
Expert Reviewers
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Environmental Protection
Agency (EPA) is seeking public
nominations of scientific and technical
experts that EPA can consider for
service as ad hoc reviewers assisting the
Science Advisory Committee on
Chemicals (SACC) with the peer review
of the Agency’s evaluation of the risks
from formaldehyde being conducted to
inform risk management decisions
under the Toxic Substances Control Act
(TSCA) and the Federal Insecticide,
SUMMARY:
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Fungicide, and Rodenticide Act (FIFRA)
programs. EPA expects to ask the SACC
to consider and review the Office of
Pollution, Prevention, and Toxics
(OPPT) and the Office of Pesticide
Programs (OPP) joint hazard
assessments for human and ecological
health; and the OPPT exposure and risk
characterizations. This SACC peer
review is in addition to prior external
peer reviews by the National Academies
of Science, Engineering, and Medicine
(NASEM), the EPA’s Human Studies
Review Board (HSRB) and the SACC.
The Agency is leveraging these peer
reviews to support further development
of the risk evaluation of formaldehyde.
To facilitate nominations, this
document provides information about
the SACC, the intended topic for the
planned peer review, the expertise
sought for this peer review, instructions
for submitting nominations to EPA, and
the Agency’s plan for selecting the ad
hoc reviewers for this peer review.
DATES: Submit your nominations on or
before January 25, 2024.
ADDRESSES: Submit your nominations to
the Designated Federal Official (DFO)
listed under FOR FURTHER INFORMATION
CONTACT.
FOR FURTHER INFORMATION CONTACT: The
DFO is Tamue Gibson, MS, Mission
Support Division (7602M), Office of
Program Support, Office of Chemical
Safety and Pollution Prevention,
Environmental Protection Agency;
telephone number: (202) 564–7642 or
call the SACC main office at (202) 564–
8450; email address: gibson.tamue@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. What action is the Agency taking?
The Agency is seeking public
nominations of scientific and technical
experts that EPA can consider for
service as ad hoc reviewers assisting the
SACC with the peer review of the
Agency’s evaluation of the risks from
formaldehyde being conducted to
inform risk management decisions
under TSCA and FIFRA programs. EPA
expects to ask the SACC to consider and
review the OPPT and OPP joint hazard
assessments for human and ecological
health; and the OPPT exposure and risk
characterizations. This SACC peer
review is in addition to prior external
peer reviews by the National Academies
of Science, Engineering, and Medicine
(NASEM), the EPA’s Human Studies
Review Board (HSRB) and the SACC.
The Agency is leveraging these peer
reviews to support further development
of the risk evaluation of formaldehyde.
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To facilitate nominations, this
document provides information about
the SACC, the intended topic for the
planned peer review, the expertise
sought for this peer review, instructions
for submitting nominations to EPA, and
the Agency’s plan for selecting the ad
hoc reviewers for this peer review.
In addition, this document provides
advance notice that EPA’s plans to
publish in the Federal Register in early
2024 separate documents to: (1)
Announce the availability of and solicit
public comment on the candidate list of
ad hoc expert reviewers for this peer
review; (2) Announce a 4-day public
meeting of the SACC anticipated to be
scheduled for May 2024; and (3)
Announce the availability of and solicit
public comment on the draft documents
and related materials submitted to the
SACC for peer review. In these future
notices, EPA will also provide
instructions for submitting written
comments and for registering to provide
oral comments at the SACC meeting.
B. What is the Agency’s authority for
taking this action?
EPA established the SACC in 2016 in
accordance with TSCA section 26(o), 15
U.S.C. 2625(o), to provide independent
advice and expert consultation 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, and supports activities under
TSCA, 15 U.S.C. 2601 et seq., the
Pollution Prevention Act (PPA), 42
U.S.C. 13101 et seq., and other
applicable statutes.
C. Does this action apply to me?
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This action is directed to the public
in general. This action may, however, be
of interest to those involved in the
manufacture, processing, distribution,
and disposal of chemical substances and
mixtures, and/or those interested in the
assessment of risks involving chemical
substances and mixtures regulated
under TSCA. 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.
D. What should I consider as I submit
my nominations to EPA?
Do not submit CBI or other sensitive
information to EPA through https://
www.regulations.gov or email. If your
nomination contains any information
that you consider to be CBI or otherwise
protected, please contact the DFO listed
under FOR FURTHER INFORMATION
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CONTACT to obtain special instructions
before submitting that information.
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 comprised of experts in
toxicology; environmental risk
assessment; exposure assessment; and
related sciences (e.g., synthetic biology,
pharmacology, biotechnology,
nanotechnology, biochemistry,
biostatistics, physiologically based
pharmacokinetic (PBPK) modeling,
computational toxicology,
epidemiology, environmental fate,
environmental engineering and
sustainability). The SACC currently
consists of 18 members. When needed,
the committee will be assisted by ad hoc
reviewers with specific expertise in the
topics under consideration.
B. Why is EPA conducting the risk
evaluation?
TSCA requires EPA to conduct risk
evaluations on prioritized chemical
substances and identifies the minimum
components the Agency must include in
all chemical substance risk evaluations.
The purpose of conducting risk
evaluations is to determine whether a
chemical substance presents an
unreasonable risk to human health or
the environment under the chemical’s
conditions of use (COUs). These
evaluations include assessing risks to
relevant potentially exposed or
susceptible subpopulations. As part of
this process, EPA integrates hazard and
exposure assessments using the best
available science and reasonably
available information to assure
decisions are based on the weight of the
scientific evidence (WoSE). For more
information about the three stages of
EPA’s process for ensuring the safety of
existing chemicals (i.e., prioritization,
risk evaluation, and risk management),
go to https://www.epa.gov/assessingand-managing-chemicals-under-tsca/
how-epa-evaluates-safety-existingchemicals.
C. What is the focus of this SACC peer
review?
EPA is planning this SACC peer
review of the Agency’s evaluation of the
risks from formaldehyde being
conducted to inform risk management
decisions under TSCA and FIFRA
programs. EPA expects to ask the SACC
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to consider and review the OPPT and
OPP joint hazard assessments for human
and ecological health; and the OPPT
exposure and risk characterizations.
This SACC peer review is in addition to
prior external peer reviews by the
NASEM, the EPA’s HSRB and the
SACC. The Agency is leveraging these
peer reviews to support further
development of the risk evaluation of
formaldehyde. The TSCA risk
evaluation of formaldehyde is expected
to comprise several modules (i.e.,
human health hazard, ecological hazard,
release and exposure assessments) and
two risk assessment documents—the
ecological risk assessment and the
human health risk assessment. As part
of the TSCA risk evaluation for
formaldehyde, OPPT is assessing
formaldehyde COUs (e.g., composite
wood products, plastics, rubber, toys,
and various adhesives and sealants).
Recommendations from the
formaldehyde SACC review will be
considered in the development of the
TSCA and FIFRA risk evaluations and
may inform other EPA efforts related to
the assessment and regulation of
formaldehyde. The Agency will be
seeking SACC review of its data
analyses and methodologies relevant to
human health hazard and exposure
analyses that have not been previously
peer reviewed.
With respect to the formaldehyde
human health hazard identification and
dose-response analysis for acute
inhalation and dermal routes, EPA is
relying on peer review from three HSRB
meetings:October 2022, May 2023, and
October 2023. The HSRB reviewed the
WoSE for EPA’s acute inhalation point
of departure (POD). Because the
Agency’s updated hazard
characterization takes into consideration
the HSRB’s recommendations, EPA will
not be soliciting review of the acute
inhalation POD or WoSE. The HSRB
reviewed relevant dermal studies, but
not the WoSE for establishing the
dermal POD. As such, EPA will seek
review of the dermal POD and WoSE.
For chronic inhalation exposure and
the cancer inhalation unit risk (IUR), the
Agency intends to defer to the draft
2022 Integrated Risk Information
System Toxicological Review of
Formaldehyde and associated 2023
review by the NASEM. In part due to
overlapping discussion of specific
studies under review by NASEM and
the HSRB, the latter recommended in its
July 2023 report that EPA conduct a
more coordinated peer review approach
with other entities (e.g., NASEM, HSRB,
SACC) regarding advice in establishing
PODs for formaldehyde. In response to
this recommendation, EPA intends to
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solicit comment on the chronic
inhalation reference concentration
(RfC).
The Agency intends to seek review of
the oral POD and WoSE including the
Agency’s assessment of the strengths
and uncertainties in the underlying data
and the utility of the data for risk
assessment purposes. The Agency
anticipates several areas of peer review
related to human and environmental
exposure to formaldehyde. EPA intends
to request SACC review of how the
environmental fate and monitoring data
are used to support the qualitative
assessment of formaldehyde exposure
via water and land pathways to human
and ecological populations. The Agency
intends to seek SACC review related to
EPA’s assessment of formaldehyde air
exposure via inhalation to terrestrial
species based on fate, exposure
modeling, monitoring, and toxicity data.
EPA intends to request SACC review
on the Agency’s interpretation of the
available occupational monitoring data
utilized in the formaldehyde
occupational exposure assessment. The
request for SACC review will focus on
unique attributes considered and relied
upon in the exposure assessment,
including use of short-term exposure
estimates, application of data relevancy,
and evidence integration strategies.
EPA intends to seek review on its
qualitative assessment of consumer
exposure via the oral route. The Agency
based this assessment on available data
for TSCA COUs, indicating that
formaldehyde is not expected to be
released from consumer products or, if
released, will not be available for uptake
via an oral exposure route (e.g.,
mouthing).
EPA intends to seek SACC review of
the approach used to assess indoor air
exposures, which considers both
modeled and monitored formaldehyde
concentrations.
EPA intends to seek review on the
interpretation and assessment of
ambient air monitoring data and its use
in the risk evaluation. However, the
Agency is not intending to request
review on the modeling methods used
to estimate formaldehyde exposure in
ambient (outdoor) air as the methods
used have been previously peer
reviewed. SACC already reviewed both
the Draft TSCA Screening Level
Approach for Assessing Ambient Air
and Water Exposures to Fenceline
Communities, Version 1.0 and the 2023
Draft Supplement to the 1,4-Dioxane
Risk Evaluation. Furthermore, feedback
from these reviews have been
incorporated into the draft
formaldehyde risk assessment.
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EPA intends to request review of the
assessment of aggregate exposure to
formaldehyde.
III. Nominations of ad hoc Reviewers
A. Why is EPA seeking nominations for
ad hoc reviewers?
As part of a broader process for
developing a pool of candidates for
SACC peer reviews, EPA is asking the
public and stakeholder communities for
nominations of scientific and technical
experts that EPA can consider as
prospective candidates for service as ad
hoc reviewers assisting the SACC with
the peer reviews. Any interested person
or organization may nominate qualified
individuals for consideration as
prospective candidates for this review
by following the instructions provided
in this document. Individuals may also
self-nominate.
Those who are selected from the pool
of prospective candidates will be
invited to attend the public meeting and
to participate in the discussion of key
issues and assumptions at the meeting.
In addition, they will be asked to review
and to help finalize the meeting
minutes.
B. What expertise is sought for this peer
review?
Individuals nominated for this SACC
peer review, should have expertise in
one or more of the following areas:
Indoor air quality; ambient air quality;
exposure science with experience in air
modeling and monitoring (for review of
air exposure analysis); risk assessment
(experience in chemicals and
environmental fate of chemicals with
background in risk assessment,
aggregate exposure and risk assessment,
industrial hygiene, ecological/terrestrial
exposure); inhalation toxicology; dermal
sensitization; statistics (experience in
air quality data for review of
interpretation of available monitoring
data, experience in interpretation of
environmental release data (e.g., Toxic
Release Inventory (TRI) and National
Emissions Inventory (NEI)));
epidemiology; and toxicology with
expertise in interpreting gastrointestinal
toxicity data associated with oral
chemical exposure. Nominees should be
scientists who have sufficient
professional qualifications, including
training and experience, to be capable of
providing expert comments on the
scientific issues for this review.
C. How do I make a nomination?
By the deadline indicated under
submit your nomination to the
DFO listed under FOR FURTHER
INFORMATION CONTACT. Each nomination
DATES,
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should include the following
information: Contact information for the
person making the nomination; name,
affiliation, and contact information for
the nominee; and the disciplinary and
specific areas of expertise of the
nominee.
D. Will ad hoc reviewers be subjected to
an ethics review?
SACC members and ad hoc reviewers
are subject to the provisions of the
Standards of Ethical Conduct for
Employees of the Executive Branch at 5
CFR part 2635, conflict of interest
statutes in Title 18 of the United States
Code and related regulations. In
anticipation of this requirement,
prospective candidates for service on
the SACC will be asked to submit
confidential financial information
which shall fully disclose, among other
financial interests, the candidate’s
employment, stocks and bonds, and
where applicable, sources of research
support. EPA will evaluate the
candidates’ financial disclosure forms to
assess whether there are financial
conflicts of interest, appearance of a loss
of impartiality, or any prior involvement
with the development of the documents
under consideration (including previous
scientific peer review) before the
candidate is considered further for
service on the SACC.
E. How will EPA select the ad hoc
reviewers?
The selection of scientists to serve as
ad hoc reviewers for the SACC is based
on the function of the Committee and
the expertise needed to address the
Agency’s charge to the Committee. No
interested scientists shall be ineligible
to serve by reason of their membership
on any other advisory committee to a
federal department or agency or their
employment by a federal department or
agency, except EPA. Other factors
considered during the selection process
include availability of the prospective
candidate to fully participate in the
Committee’s reviews, absence of any
conflicts of interest or appearance of
loss of impartiality, independence with
respect to the matters under review, and
lack of bias. Although financial conflicts
of interest, the appearance of loss of
impartiality, lack of independence, and
bias may result in non-selection, the
absence of such concerns does not
assure that a candidate will be selected
to serve on the SACC.
Numerous qualified candidates are
often identified for SACC reviews.
Therefore, selection decisions involve
carefully weighing a number of factors
including the candidates’ areas of
expertise and professional
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qualifications, and achieving an overall
balance of different scientific
perspectives across reviewers. The
Agency will consider all nominations of
prospective candidates for service as ad
hoc reviewers for the SACC that are
received on or before the date listed in
the DATES section of this document.
D. How can I stay informed about SACC
activities?
IV. Advance Notice of Other Planned
Activities
As indicated previously, EPA’s plans
to publish separate documents in the
Federal Register in early 2024 to
announce the planned activities related
to this peer review that are briefly
discussed in this unit.
(Authority: 15 U.S.C. 2625(o); 5 U.S.C 10)
A. Planned Public Review of a
Candidate List of ad hoc Reviewers
Being Considered
Although the final selection of ad hoc
reviewers is a discretionary function of
the Agency, EPA plans to make
available for public comment a
candidate list of ad hoc expert reviewers
for this peer review in early 2024. The
‘‘List of Candidates’’ provides the names
and biographical sketches of all
interested and available nominees
identified from respondents to this
solicitation, other nominations received,
and any additional candidates identified
by EPA staff.
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B. Planned Public Meeting
EPA plans to announce a 4-day public
meeting of the SACC that is anticipated
to be scheduled for May 2024. At that
time, EPA will provide logistical
information and instructions for
registering to attend and/or provide oral
comments at the SACC meeting.
C. Planned Public Review of Materials
Submitted for Peer Review
EPA plans to announce the
availability of and solicit public
comment on the draft documents and
related materials submitted to the SACC
for peer review. At that time, EPA will
provide instructions for accessing the
materials provided to the SACC and will
provide instructions for submitting
written comments and instructions for
registering to provide oral comments at
the SACC meeting. These materials will
also be available in Docket ID No. EPA–
HQ–OPPT–2022–0613 at https://
www.regulations.gov and through the
SACC website at https://www.epa.gov/
tsca-peer-review. 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 through the SACC website.
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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.
Dated: December 20, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2023–28430 Filed 12–22–23; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OLEM–2023–0451; FRL–11466–
01–OLEM]
Waste Reduction Model (WARM)
Version 16: Request for Public
Comment
Environmental Protection
Agency (EPA).
ACTION: Notice of availability.
AGENCY:
The Environmental Protection
Agency (EPA) has released the Waste
Reduction Model (WARM) version 16
and its supporting documentation, along
with the WARM v16 methodology
external peer review report and the
WARM v16 data quality assessment
report. WARM is a tool that estimates
the potential greenhouse gas emissions,
energy savings and economic impacts of
baseline and alternative waste
management practices of materials. This
Notice is inviting public comment on
WARM v16 and its supporting
documentation from a broad range of
individuals and organizations. The EPA
will consider the public comments
received to inform future improvements
to WARM.
DATES: Comments must be submitted on
or before February 9, 2024.
ADDRESSES:
Written Comments: Submit your
written comments, identified by Docket
ID No. EPA–HQ–OLEM–2023–0451,
through the Federal eRulemaking Portal
at https://www.regulations.gov/. Follow
the online instructions for submitting
comments.
Once submitted, comments cannot be
edited or removed from Regulations.gov.
EPA may publish any comment received
to its public docket. Do not submit
electronically any information you
consider to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
SUMMARY:
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Multimedia submissions (audio, video,
etc.) must be accompanied by a written
comment. Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at:
https://www.epa.gov/dockets.
Instructions: All submissions received
must include the Docket ID No. EPA–
HQ–OLEM–2023–0451 for this notice.
Comments received may be posted
without change to https://
www.regulations.gov/, including any
personal information provided. For
detailed instructions on sending
comments, see the ‘‘Public
Participation’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
Priscilla Halloran, Resource
Conservation and Sustainability
Division, Office of Resource
Conservation and Recovery, Office of
Land and Emergency Management, Mail
Code 5306T, Environmental Protection
Agency, 1200 Pennsylvania Avenue
NW, Washington, DC 20460; telephone
number: 202–566–0311, or Kimberly
Cochran (same address); telephone
number: 202–566–0308; email address:
orcrWARMquestions@epa.gov. For more
information on WARM, please visit
https://epa.gov/warm.
SUPPLEMENTARY INFORMATION:
I. Public Participation
Response to this request for public
comment is voluntary. Submit your
comments, identified by Docket ID No.
EPA–HQ–OLEM–2023–0451, at https://
www.regulations.gov/ (our preferred
method), or the other methods
identified in the ADDRESSES section.
Once submitted, comments cannot be
edited or removed from the docket. The
Environmental Protection Agency may
publish any comment received to its
public docket. Responses to this request
for public comment may be submitted
by a single party or a team. Responses
will only be accepted using Microsoft
Word (.docx) or Adobe PDF (.pdf) file
formats. The response document should
contain the following:
D Two clearly delineated sections: (1)
Cover page with company name and
contact information; and (2) responses
by topic and/or that address specific
EPA questions.
D 1-inch margins (top, bottom, and
sides).
D Times New Roman and 12-point
font.
Comments containing references,
studies, research, and other empirical
data that are not widely published
should include copies or electronic
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]]>Agencies
[Federal Register Volume 88, Number 246 (Tuesday, December 26, 2023)]
[Notices]
[Pages 88910-88913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28430]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0613; FRL-11608-01-OCSPP]
Formaldehyde; Draft Risk Evaluation Peer Review by the Science
Advisory Committee on Chemicals (SACC); Request for Nominations of ad
hoc Expert Reviewers
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is seeking public
nominations of scientific and technical experts that EPA can consider
for service as ad hoc reviewers assisting the Science Advisory
Committee on Chemicals (SACC) with the peer review of the Agency's
evaluation of the risks from formaldehyde being conducted to inform
risk management decisions under the Toxic Substances Control Act (TSCA)
and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
programs. EPA expects to ask the SACC to consider and review the Office
of Pollution, Prevention, and Toxics (OPPT) and the Office of Pesticide
Programs (OPP) joint hazard assessments for human and ecological
health; and the OPPT exposure and risk characterizations. This SACC
peer review is in addition to prior external peer reviews by the
National Academies of Science, Engineering, and Medicine (NASEM), the
EPA's Human Studies Review Board (HSRB) and the SACC. The Agency is
leveraging these peer reviews to support further development of the
risk evaluation of formaldehyde. To facilitate nominations, this
document provides information about the SACC, the intended topic for
the planned peer review, the expertise sought for this peer review,
instructions for submitting nominations to EPA, and the Agency's plan
for selecting the ad hoc reviewers for this peer review.
DATES: Submit your nominations on or before January 25, 2024.
ADDRESSES: Submit your nominations to the Designated Federal Official
(DFO) listed under FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: The DFO is Tamue Gibson, MS, Mission
Support Division (7602M), Office of Program Support, Office of Chemical
Safety and Pollution Prevention, Environmental Protection Agency;
telephone number: (202) 564-7642 or call the SACC main office at (202)
564-8450; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. What action is the Agency taking?
The Agency is seeking public nominations of scientific and
technical experts that EPA can consider for service as ad hoc reviewers
assisting the SACC with the peer review of the Agency's evaluation of
the risks from formaldehyde being conducted to inform risk management
decisions under TSCA and FIFRA programs. EPA expects to ask the SACC to
consider and review the OPPT and OPP joint hazard assessments for human
and ecological health; and the OPPT exposure and risk
characterizations. This SACC peer review is in addition to prior
external peer reviews by the National Academies of Science,
Engineering, and Medicine (NASEM), the EPA's Human Studies Review Board
(HSRB) and the SACC. The Agency is leveraging these peer reviews to
support further development of the risk evaluation of formaldehyde.
[[Page 88911]]
To facilitate nominations, this document provides information about the
SACC, the intended topic for the planned peer review, the expertise
sought for this peer review, instructions for submitting nominations to
EPA, and the Agency's plan for selecting the ad hoc reviewers for this
peer review.
In addition, this document provides advance notice that EPA's plans
to publish in the Federal Register in early 2024 separate documents to:
(1) Announce the availability of and solicit public comment on the
candidate list of ad hoc expert reviewers for this peer review; (2)
Announce a 4-day public meeting of the SACC anticipated to be scheduled
for May 2024; and (3) Announce the availability of and solicit public
comment on the draft documents and related materials submitted to the
SACC for peer review. In these future notices, EPA will also provide
instructions for submitting written comments and for registering to
provide oral comments at the SACC meeting.
B. What is the Agency's authority for taking this action?
EPA established the SACC in 2016 in accordance with TSCA section
26(o), 15 U.S.C. 2625(o), to provide independent advice and expert
consultation 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,
and supports activities under TSCA, 15 U.S.C. 2601 et seq., the
Pollution Prevention Act (PPA), 42 U.S.C. 13101 et seq., and other
applicable statutes.
C. Does this action apply to me?
This action is directed to the public in general. This action may,
however, be of interest to those involved in the manufacture,
processing, distribution, and disposal of chemical substances and
mixtures, and/or those interested in the assessment of risks involving
chemical substances and mixtures regulated under TSCA. 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.
D. What should I consider as I submit my nominations to EPA?
Do not submit CBI or other sensitive information to EPA through
https://www.regulations.gov or email. If your nomination contains any
information that you consider to be CBI or otherwise protected, please
contact the DFO listed under FOR FURTHER INFORMATION CONTACT to obtain
special instructions before submitting that information.
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 comprised of experts in
toxicology; environmental risk assessment; exposure assessment; and
related sciences (e.g., synthetic biology, pharmacology, biotechnology,
nanotechnology, biochemistry, biostatistics, physiologically based
pharmacokinetic (PBPK) modeling, computational toxicology,
epidemiology, environmental fate, environmental engineering and
sustainability). The SACC currently consists of 18 members. When
needed, the committee will be assisted by ad hoc reviewers with
specific expertise in the topics under consideration.
B. Why is EPA conducting the risk evaluation?
TSCA requires EPA to conduct risk evaluations on prioritized
chemical substances and identifies the minimum components the Agency
must include in all chemical substance risk evaluations. The purpose of
conducting risk evaluations is to determine whether a chemical
substance presents an unreasonable risk to human health or the
environment under the chemical's conditions of use (COUs). These
evaluations include assessing risks to relevant potentially exposed or
susceptible subpopulations. As part of this process, EPA integrates
hazard and exposure assessments using the best available science and
reasonably available information to assure decisions are based on the
weight of the scientific evidence (WoSE). For more information about
the three stages of EPA's process for ensuring the safety of existing
chemicals (i.e., prioritization, risk evaluation, and risk management),
go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/how-epa-evaluates-safety-existing-chemicals.
C. What is the focus of this SACC peer review?
EPA is planning this SACC peer review of the Agency's evaluation of
the risks from formaldehyde being conducted to inform risk management
decisions under TSCA and FIFRA programs. EPA expects to ask the SACC to
consider and review the OPPT and OPP joint hazard assessments for human
and ecological health; and the OPPT exposure and risk
characterizations. This SACC peer review is in addition to prior
external peer reviews by the NASEM, the EPA's HSRB and the SACC. The
Agency is leveraging these peer reviews to support further development
of the risk evaluation of formaldehyde. The TSCA risk evaluation of
formaldehyde is expected to comprise several modules (i.e., human
health hazard, ecological hazard, release and exposure assessments) and
two risk assessment documents--the ecological risk assessment and the
human health risk assessment. As part of the TSCA risk evaluation for
formaldehyde, OPPT is assessing formaldehyde COUs (e.g., composite wood
products, plastics, rubber, toys, and various adhesives and sealants).
Recommendations from the formaldehyde SACC review will be
considered in the development of the TSCA and FIFRA risk evaluations
and may inform other EPA efforts related to the assessment and
regulation of formaldehyde. The Agency will be seeking SACC review of
its data analyses and methodologies relevant to human health hazard and
exposure analyses that have not been previously peer reviewed.
With respect to the formaldehyde human health hazard identification
and dose-response analysis for acute inhalation and dermal routes, EPA
is relying on peer review from three HSRB meetings:October 2022, May
2023, and October 2023. The HSRB reviewed the WoSE for EPA's acute
inhalation point of departure (POD). Because the Agency's updated
hazard characterization takes into consideration the HSRB's
recommendations, EPA will not be soliciting review of the acute
inhalation POD or WoSE. The HSRB reviewed relevant dermal studies, but
not the WoSE for establishing the dermal POD. As such, EPA will seek
review of the dermal POD and WoSE.
For chronic inhalation exposure and the cancer inhalation unit risk
(IUR), the Agency intends to defer to the draft 2022 Integrated Risk
Information System Toxicological Review of Formaldehyde and associated
2023 review by the NASEM. In part due to overlapping discussion of
specific studies under review by NASEM and the HSRB, the latter
recommended in its July 2023 report that EPA conduct a more coordinated
peer review approach with other entities (e.g., NASEM, HSRB, SACC)
regarding advice in establishing PODs for formaldehyde. In response to
this recommendation, EPA intends to
[[Page 88912]]
solicit comment on the chronic inhalation reference concentration
(RfC).
The Agency intends to seek review of the oral POD and WoSE
including the Agency's assessment of the strengths and uncertainties in
the underlying data and the utility of the data for risk assessment
purposes. The Agency anticipates several areas of peer review related
to human and environmental exposure to formaldehyde. EPA intends to
request SACC review of how the environmental fate and monitoring data
are used to support the qualitative assessment of formaldehyde exposure
via water and land pathways to human and ecological populations. The
Agency intends to seek SACC review related to EPA's assessment of
formaldehyde air exposure via inhalation to terrestrial species based
on fate, exposure modeling, monitoring, and toxicity data.
EPA intends to request SACC review on the Agency's interpretation
of the available occupational monitoring data utilized in the
formaldehyde occupational exposure assessment. The request for SACC
review will focus on unique attributes considered and relied upon in
the exposure assessment, including use of short-term exposure
estimates, application of data relevancy, and evidence integration
strategies.
EPA intends to seek review on its qualitative assessment of
consumer exposure via the oral route. The Agency based this assessment
on available data for TSCA COUs, indicating that formaldehyde is not
expected to be released from consumer products or, if released, will
not be available for uptake via an oral exposure route (e.g.,
mouthing).
EPA intends to seek SACC review of the approach used to assess
indoor air exposures, which considers both modeled and monitored
formaldehyde concentrations.
EPA intends to seek review on the interpretation and assessment of
ambient air monitoring data and its use in the risk evaluation.
However, the Agency is not intending to request review on the modeling
methods used to estimate formaldehyde exposure in ambient (outdoor) air
as the methods used have been previously peer reviewed. SACC already
reviewed both the Draft TSCA Screening Level Approach for Assessing
Ambient Air and Water Exposures to Fenceline Communities, Version 1.0
and the 2023 Draft Supplement to the 1,4-Dioxane Risk Evaluation.
Furthermore, feedback from these reviews have been incorporated into
the draft formaldehyde risk assessment.
EPA intends to request review of the assessment of aggregate
exposure to formaldehyde.
III. Nominations of ad hoc Reviewers
A. Why is EPA seeking nominations for ad hoc reviewers?
As part of a broader process for developing a pool of candidates
for SACC peer reviews, EPA is asking the public and stakeholder
communities for nominations of scientific and technical experts that
EPA can consider as prospective candidates for service as ad hoc
reviewers assisting the SACC with the peer reviews. Any interested
person or organization may nominate qualified individuals for
consideration as prospective candidates for this review by following
the instructions provided in this document. Individuals may also self-
nominate.
Those who are selected from the pool of prospective candidates will
be invited to attend the public meeting and to participate in the
discussion of key issues and assumptions at the meeting. In addition,
they will be asked to review and to help finalize the meeting minutes.
B. What expertise is sought for this peer review?
Individuals nominated for this SACC peer review, should have
expertise in one or more of the following areas: Indoor air quality;
ambient air quality; exposure science with experience in air modeling
and monitoring (for review of air exposure analysis); risk assessment
(experience in chemicals and environmental fate of chemicals with
background in risk assessment, aggregate exposure and risk assessment,
industrial hygiene, ecological/terrestrial exposure); inhalation
toxicology; dermal sensitization; statistics (experience in air quality
data for review of interpretation of available monitoring data,
experience in interpretation of environmental release data (e.g., Toxic
Release Inventory (TRI) and National Emissions Inventory (NEI)));
epidemiology; and toxicology with expertise in interpreting
gastrointestinal toxicity data associated with oral chemical exposure.
Nominees should be scientists who have sufficient professional
qualifications, including training and experience, to be capable of
providing expert comments on the scientific issues for this review.
C. How do I make a nomination?
By the deadline indicated under DATES, submit your nomination to
the DFO listed under FOR FURTHER INFORMATION CONTACT. Each nomination
should include the following information: Contact information for the
person making the nomination; name, affiliation, and contact
information for the nominee; and the disciplinary and specific areas of
expertise of the nominee.
D. Will ad hoc reviewers be subjected to an ethics review?
SACC members and ad hoc reviewers are subject to the provisions of
the Standards of Ethical Conduct for Employees of the Executive Branch
at 5 CFR part 2635, conflict of interest statutes in Title 18 of the
United States Code and related regulations. In anticipation of this
requirement, prospective candidates for service on the SACC will be
asked to submit confidential financial information which shall fully
disclose, among other financial interests, the candidate's employment,
stocks and bonds, and where applicable, sources of research support.
EPA will evaluate the candidates' financial disclosure forms to assess
whether there are financial conflicts of interest, appearance of a loss
of impartiality, or any prior involvement with the development of the
documents under consideration (including previous scientific peer
review) before the candidate is considered further for service on the
SACC.
E. How will EPA select the ad hoc reviewers?
The selection of scientists to serve as ad hoc reviewers for the
SACC is based on the function of the Committee and the expertise needed
to address the Agency's charge to the Committee. No interested
scientists shall be ineligible to serve by reason of their membership
on any other advisory committee to a federal department or agency or
their employment by a federal department or agency, except EPA. Other
factors considered during the selection process include availability of
the prospective candidate to fully participate in the Committee's
reviews, absence of any conflicts of interest or appearance of loss of
impartiality, independence with respect to the matters under review,
and lack of bias. Although financial conflicts of interest, the
appearance of loss of impartiality, lack of independence, and bias may
result in non-selection, the absence of such concerns does not assure
that a candidate will be selected to serve on the SACC.
Numerous qualified candidates are often identified for SACC
reviews. Therefore, selection decisions involve carefully weighing a
number of factors including the candidates' areas of expertise and
professional
[[Page 88913]]
qualifications, and achieving an overall balance of different
scientific perspectives across reviewers. The Agency will consider all
nominations of prospective candidates for service as ad hoc reviewers
for the SACC that are received on or before the date listed in the
DATES section of this document.
IV. Advance Notice of Other Planned Activities
As indicated previously, EPA's plans to publish separate documents
in the Federal Register in early 2024 to announce the planned
activities related to this peer review that are briefly discussed in
this unit.
A. Planned Public Review of a Candidate List of ad hoc Reviewers Being
Considered
Although the final selection of ad hoc reviewers is a discretionary
function of the Agency, EPA plans to make available for public comment
a candidate list of ad hoc expert reviewers for this peer review in
early 2024. The ``List of Candidates'' provides the names and
biographical sketches of all interested and available nominees
identified from respondents to this solicitation, other nominations
received, and any additional candidates identified by EPA staff.
B. Planned Public Meeting
EPA plans to announce a 4-day public meeting of the SACC that is
anticipated to be scheduled for May 2024. At that time, EPA will
provide logistical information and instructions for registering to
attend and/or provide oral comments at the SACC meeting.
C. Planned Public Review of Materials Submitted for Peer Review
EPA plans to announce the availability of and solicit public
comment on the draft documents and related materials submitted to the
SACC for peer review. At that time, EPA will provide instructions for
accessing the materials provided to the SACC and will provide
instructions for submitting written comments and instructions for
registering to provide oral comments at the SACC meeting. These
materials will also be available in Docket ID No. EPA-HQ-OPPT-2022-0613
at https://www.regulations.gov and through the SACC website at https://www.epa.gov/tsca-peer-review. 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
through the SACC website.
D. How can I stay informed about SACC activities?
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 10)
Dated: December 20, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-28430 Filed 12-22-23; 8:45 am]
BILLING CODE 6560-50-P
