[Federal Register Volume 89, Number 52 (Friday, March 15, 2024)]
[Notices]
[Pages 18933-18935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05554]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2023-0613; FRL-11608-03-OCSPP]


Formaldehyde; Draft Risk Evaluation Peer Review by the Science 
Advisory Committee on Chemicals (SACC); Notice of Availability, Public 
Meetings and Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA or ``Agency'') is 
announcing the availability of and soliciting public comment on the 
2024 draft risk evaluation for formaldehyde prepared under the Toxic 
Substances Control Act (TSCA). The draft risk

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evaluation is available for public review and comment. It will also be 
submitted to the SACC for peer review. EPA is also announcing that 
there will be two virtual public meetings of the SACC. The SACC will 
consider and review the draft risk evaluation at a 4-day virtual peer 
review public meeting that will be held on May 20-23, 2024. In 
addition, a virtual preparatory public meeting will be held on May 7, 
2024, for the SACC to consider the scope and clarity of the draft 
charge questions for the peer review.

DATES: 
    Virtual Preparatory Public Meeting: May 7, 2024, from 1 p.m. to 
approximately 4 p.m. (EST). You must register to receive the webcast 
meeting link and audio teleconference information. Online registration 
will be available beginning in April 2024. To request time to present 
oral comments during the virtual preparatory public meeting, you must 
register online by noon, May 3, 2024. For those not making oral 
comments during the virtual preparatory public meeting, registration 
will remain open through the end of the meeting.
    Virtual Peer Review Public Meeting: May 20-23, 2024, from 10 a.m. 
to approximately 5 p.m. (EST) (as needed, updated times for each day 
may be provided in the meeting agenda that will be posted in the docket 
at https://www.regulations.gov and available through the SACC website 
at https://www.epa.gov/tsca-peer-review). You must register online to 
receive the webcast meeting link and audio teleconference information. 
Online registration will be available beginning in April 2024. To make 
oral comments during the virtual peer review public meeting and 
included on the meeting agenda, you must register by noon, May 13, 
2024. For those not making oral comments, registration for this meeting 
will remain open through the last day of the meeting.
    Comments: Submit comments on the draft risk evaluation on or before 
May 14, 2024. Submit comments intended for the virtual preparatory 
public meeting on or before noon, May 3, 2024. For additional 
instructions, see Unit III. of SUPPLEMENTARY INFORMATION.
    To request special accommodations: To allow sufficient time for EPA 
to process your request before the applicable meetings, please submit 
your request by April 30, 2024.

ADDRESSES: 
    Virtual Public Meetings: You must register for each meeting to 
receive the webcast meeting link and audio teleconference information. 
Access to these virtual meetings will be provided through a webcast 
platform such as Zoomgov.com, streaming service, and audio 
teleconference.
    Meeting Registration: For information and instructions on how to 
register and access these virtual public meetings, please refer to the 
SACC website at https://www.epa.gov/tsca-peer-review. After 
registering, you will receive the webcast meeting link and audio 
teleconference information.
    Comments: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2023-0613, through the Federal eRulemaking 
Portal at https://www.regulations.gov. to docket ID No. EPA-HQ-OPPT-
2023-0613. Follow the online instructions for submitting comments. Do 
not submit electronically any information you consider to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Additional instructions on 
commenting and visiting the docket, along with more information about 
dockets generally, is available at https://www.epa.gov/dockets.
    To request special accommodations: For information on access or 
services for individuals with disabilities, and to request 
accommodation for a disability, please contact the DFO listed under FOR 
FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Official (DFO) 
is Tamue Gibson, Mission Support Division (7602M), Office of Program 
Support, Office of Chemical Safety and Pollution Prevention, 
Environmental Protection Agency; telephone number: (202) 564-7642 or 
SACC main office number: (202) 564-8450; email address: 
[email protected].
    For general information: You may subscribe to the Office of 
Chemical Safety and Pollution Prevention listserv for alerts regarding 
this and other SACC related activities at https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. What action is the Agency taking?

    EPA is announcing the availability of and soliciting public comment 
on the 2024 draft risk evaluation for formaldehyde. EPA is also 
announcing a 4-day virtual peer review public meeting on May 20-23, 
2024, for the SACC to consider and review the draft risk evaluation 
document. A virtual preparatory public meeting will be held on May 7, 
2024, for the SACC and the public to consider and ask questions 
regarding the scope and clarity of the draft charge questions. EPA will 
be soliciting comments from the SACC on the Office of Pollution 
Prevention and Toxics (OPPT) and 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 SACC peer reviews of scientific approaches used 
in previous TSCA risk evaluations. These previous peer reviews have 
informed the 2024 draft risk evaluation for formaldehyde.
    This document provides instructions for accessing the materials, 
submitting written comments, and registering to provide oral comments 
and attend the public meetings.

B. What is the Agency's authority for taking this action?

    EPA established the SACC in 2016 in accordance with the TSCA, 15 
U.S.C. 2625(o), 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, 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.

C. Does this action apply to me?

    This action is directed to the public in general and may be of 
particular interest to those involved in the manufacture, processing, 
distribution, and disposal of the subject chemical substance, and/or 
those interested in the assessment of risks involving chemical 
substances and mixtures regulated under TSCA.

D. What should I consider as I submit my comments to EPA?

    1. Submitting CBI. Do not electronically submit any information you 
consider to be CBI or other information whose disclosure is restricted 
by statute. Copyrighted material will not be posted without explicit 
permission of the copyright holder. Members of the public should also 
be aware that personal contact information, if included in any written 
comments, may be posted on the internet at https://www.regulations.gov. 
If your comment contains any information that you consider to be CBI

[[Page 18935]]

or otherwise protected, please contact the DFO listed under FOR FURTHER 
INFORMATION CONTACT to obtain special instructions before submitting 
that information.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets#tips. See also the instructions in Unit III.C.

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, and 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 did EPA develop these documents?

    TSCA requires EPA to conduct risk evaluations on high priority 
chemical substances to determine whether a chemical substance presents 
an unreasonable risk to human health or the environment under the 
chemical's conditions of use. EPA must also determine whether a 
chemical substance presents unreasonable risk to potentially exposed or 
susceptible subpopulations deemed relevant by the Administrator. 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. 
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.

III. Public Meeting of the SACC

A. What is the purpose of the virtual peer review public meeting?

    EPA is planning this SACC peer review of the Agency's draft 
evaluation of the risks from formaldehyde to inform risk management 
decisions under TSCA. OPPT collaborated with OPP to develop hazard 
assessments for human and ecological health. EPA expects to ask the 
SACC to consider and review these joint hazard assessments in addition 
to 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 SACC peer reviews of scientific approaches used 
in previous TSCA risk evaluations. The Agency is leveraging these peer 
reviews to support further development of the risk evaluation of 
formaldehyde. The TSCA risk evaluation of formaldehyde is comprised of 
several modules (i.e., human health hazard, ecological hazard, release 
and exposure assessments) and two risk assessment documents--the 
environmental risk assessment and the human health risk assessment. As 
part of the draft risk evaluation for formaldehyde, OPPT is assessing 
formaldehyde conditions of use.
    Recommendations from the formaldehyde SACC review and public 
comments will be considered in the development of the final TSCA risk 
evaluation for formaldehyde 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. For additional information, please see the Federal 
Register notice of December 26, 2023 (88 FR 88910; FRL-11608-01-OCSPP).

B. How can I access the documents?

    The 2024 draft risk evaluation for formaldehyde and related 
documents, including background documents, related supporting 
materials, and draft charge questions, are available in the docket. As 
additional background materials become available, EPA will include 
those additional background documents (e.g., SACC members and 
consultants participating in this meeting and the meeting agenda) in 
the docket. All of these documents will be available at https://www.regulations.gov (docket ID No. EPA-HQ-OPPT-2023-0613) and through 
links on the SACC website at https://www.epa.gov/tsca-peer-review.
    After the public meeting, the SACC will prepare the meeting minutes 
and final report document summarizing its recommendations to the EPA, 
which will also be available in the docket and through the SACC 
website.

C. How can I provide comments?

    To ensure proper receipt of comments, it is imperative that you 
identify docket ID No. EPA-HQ-OPPT-2023-0613 in the subject line on the 
first page of your comments and follow the instructions in Unit I.D. 
and in this unit.
    1. Written comments. Submit written comments by the deadlines set 
in the DATES section of this document and as described in the ADDRESSES 
section of this document.
    2. Oral comments. To request time to present oral comments during 
one of the virtual public meetings, you must register online by the 
deadlines set in the DATES section of this document. Oral comments 
during the virtual public meetings are limited to 5 minutes. In 
addition, each speaker should submit a written copy of their oral 
comments and any supporting materials (e.g., presentation slides) to 
the DFO prior to the meetings for distribution to the SACC by the DFO.
    Authority: 15 U.S.C. 2625(o); 5 U.S.C. 10.

    Dated: March 11, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2024-05554 Filed 3-14-24; 8:45 am]
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