
[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]
BILLING CODE 6560-50-P


