[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]
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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.
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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]
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