Formaldehyde; Draft Risk Evaluation Peer Review by the Science Advisory Committee on Chemicals (SACC); Request for Comments on Experts Being Considered for Participation as Ad Hoc Peer Reviewers
| Published date | 28 February 2024 |
| Record Number | 2024-04131 |
| Citation | 89 FR 14648 |
| Court | Environmental Protection Agency |
| Section | Notices |
Federal Register, Volume 89 Issue 40 (Wednesday, February 28, 2024)
[Federal Register Volume 89, Number 40 (Wednesday, February 28, 2024)]
[Notices]
[Pages 14648-14649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04131]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0613; FRL-11608-02-OCSPP]
Formaldehyde; Draft Risk Evaluation Peer Review by the Science
Advisory Committee on Chemicals (SACC); Request for Comments on Experts
Being Considered for Participation as Ad Hoc Peer Reviewers
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and soliciting public comments on the list of
candidates under consideration for selection as ad hoc peer reviewers
assisting the Science Advisory Committee on Chemicals (SACC) with their
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). The list of candidates provides the
names and biographical sketches of all interested and available
candidates identified from the responses to the call for nominations
and other sources. Public comments on these candidates will be used to
assist the Agency in selecting approximately 10-15 ad hoc peer
reviewers to assist the SACC with the identified peer review.
DATES: Submit your comments on or before March 14, 2024.
ADDRESSES: Submit comments, identified by docket identification (ID)
number EPA-HQ-OPPT-2023-0613, through the Federal eRulemaking Portal at
https://www.regulations.gov. 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.
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;
email address: [email protected]; or call the SACC main office at
(202) 564-8450.
SUPPLEMENTARY INFORMATION:
I. General Information
A. What action is the Agency taking?
The Agency is seeking public comments on scientific and technical
experts that EPA is considering for service as ad hoc peer 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. The Office of Pollution Prevention and Toxics
(OPPT) collaborated with the Office of Pesticide Programs (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
related scientific issues. The Agency is leveraging these peer reviews
to support further development of the risk evaluation of formaldehyde.
For additional information, please see the Agency's request for
nominations of ad hoc expert reviewers that appeared in the Federal
Register of December 26, 2023 (88 FR 88910 (FRL-11608-01-OCSPP)).
B. What is the Agency's authority for taking this action?
EPA established the SACC in 2016 in accordance with TSCA, 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 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.
[[Page 14649]]
D. What should I consider as I prepare my comments for EPA?
Do not electronically submit any information you consider to be
Confidential Business Information (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 or otherwise protected, please contact the
DFO listed under FOR FURTHER INFORMATION CONTACT to obtain special
instructions before submitting that information.
E. 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.
II. Background
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. 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 related scientific issues.
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
conditions of use (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 risk evaluation 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).
III. Request for Comments on the Candidates List
A. Will ad hoc reviewers be subjected to an ethics review?
EPA is currently seeking public comments on all interested and
available candidates, without prescreening for ethics concerns.
However, SACC members and ad hoc peer 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.
B. How will EPA select the ad hoc reviewers?
The selection of scientists to serve as ad hoc peer 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 qualifications, and achieving an overall balance of
different scientific perspectives across reviewers.
Authority: 15 U.S.C. 2625(o); 5 U.S.C 10.
Dated: February 23, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-04131 Filed 2-27-24; 8:45 am]
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