[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 18934]]
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]
BILLING CODE 6560-50-P