Notice2023-13294
Letter Peer Review; 2023 White Paper on the Quantitative Human Health Approach To Be Applied in the Risk Evaluation for Asbestos Part 2; Request for Nominations of Expert Reviewers
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Published
June 22, 2023
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or "Agency") is seeking public nominations of scientific and technical experts to review the "2023 White Paper on the Quantitative Human Health Approach to be Applied in the Risk Evaluation for Asbestos Part 2." The white paper will be released for public review and comment in late July 2023 and subsequently submitted for letter peer review. EPA currently anticipates selecting approximately 10-15 expert reviewers and plans to make a list of candidates under consideration as prospective letter reviewers for this review available for public comment by early August 2023.
Full Text
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<title>Federal Register, Volume 88 Issue 119 (Thursday, June 22, 2023)</title>
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[Federal Register Volume 88, Number 119 (Thursday, June 22, 2023)]
[Notices]
[Pages 40819-40821]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13294]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0309; FRL-9347-04-OCSPP]
Letter Peer Review; 2023 White Paper on the Quantitative Human
Health Approach To Be Applied in the Risk Evaluation for Asbestos Part
2; Request for Nominations of Expert Reviewers
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA or ``Agency'') is
seeking public nominations of scientific and technical experts to
review the ``2023 White Paper on the Quantitative Human Health Approach
to be Applied in the Risk Evaluation for Asbestos Part 2.'' The white
paper will be released for public review and comment in late July 2023
and subsequently submitted for letter peer review. EPA currently
anticipates selecting approximately 10-15 expert reviewers and plans to
make a list of candidates under consideration as prospective letter
reviewers for this review available for public comment by early August
2023.
DATES: Submit your nominations to EPA on or before July 24, 2023.
ADDRESSES: Submit your nominations via email to the Designated Federal
Official (DFO) listed under FOR FURTHER INFORMATION CONTACT. Do not use
email to submit any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute.
FOR FURTHER INFORMATION CONTACT: Contact the DFO, Tamue Gibson, Office
of Program Support (7602M), Office of Chemical Safety and Pollution
Prevention, Environmental Protection Agency; telephone number: (202)
564-7642 or call the Science Advisory Committee on Chemicals (SACC)
main office number: (202) 564-8450; email address:
<a href="/cdn-cgi/l/email-protection#81e6e8e3f2eeefaff5e0ecf4e4c1e4f1e0afe6eef7"><span class="__cf_email__" data-cfemail="dcbbb5beafb3b2f2a8bdb1a9b99cb9acbdf2bbb3aa">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. What action is the Agency taking?
The Agency is seeking public nominations of scientific and
technical experts that the EPA can consider for service as peer
reviewers for the review of the ``2023 White Paper on the Quantitative
Human Health Approach to be Applied in the Risk Evaluation for Asbestos
Part 2.'' EPA will be soliciting comments from the reviewers on the
quantitative approach to assessing cancer and non-cancer human health
hazards for Part 2 of the risk evaluation for asbestos.
This document provides instructions for submitting nominations of
scientific and technical experts that EPA can consider as prospective
candidates to serve as peer reviewers. EPA will publish a separate
document in the Federal Register in late July 2023 to announce the
availability of the white paper and solicit public comments.
B. What is the Agency's authority for taking this action?
TSCA section 6(b) requires that EPA conduct risk evaluations on
existing chemical substances and identifies the minimum components EPA
must include in all chemical substance risk evaluations (15 U.S.C.
2605(b)). The risk evaluation must not consider costs or other non-risk
factors (15 U.S.C. 2605(b)(4)(F)(iii)). The specific risk evaluation
process is set out in 40 CFR part 702 and summarized on EPA's website:
<a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca</a>.
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 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?
1. Submitting CBI. 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. Do not submit CBI or
other sensitive information to EPA via <a href="https://www.regulations.gov">https://www.regulations.gov</a> or
email.
II. Nominations for Peer Reviewers
A. Why is EPA seeking nominations for peer reviewers?
As part of a broader process for developing a pool of candidates
for peer reviews, EPA is asking the public and stakeholder communities
for nominations of scientific and technical experts that EPA can
consider as prospective candidates to serve as peer reviewers. 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 asked to review the white paper for asbestos and to help finalize
the letter review report.
B. What expertise is sought for this peer review?
Individuals nominated for this peer review, should have expertise
in one or more of the following areas: Asbestos epidemiology;
epidemiology and biostatistics; asbestos exposure measurement; and
application of epidemiology in risk assessment. 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
[[Page 40820]]
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?
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 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.
E. How will EPA select the letter peer reviewers?
The selection of scientists and technical experts to serve as peer
reviewers is based on the expertise needed to address the Agency's
charge to the reviewers. No interested scientists or technical experts
shall be ineligible to serve by reason of their membership on an
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 Letter Review,
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 as a peer reviewer.
Numerous qualified candidates are often identified for the review.
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. The Agency will consider all nominations
of prospective candidates for service as peer reviewers that are
received on or before the date listed in the DATES section of this
document. However, the final selection of peer reviewers is a
discretionary function of the Agency. At this time, EPA anticipates
selecting 10-15 reviewers in the review of the designated topic.
EPA plans to make a list of candidates under consideration as
prospective peer reviewers for this review available for public comment
by early August 2023. The list will be available in the docket at:
<a href="http://www.regulations.gov">http://www.regulations.gov</a> (docket ID number EPA-HQ-OPPT-2023-0309).
You may also subscribe to the following listserv for alerts regarding
this and other peer review related activities: <a href="https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101">https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101</a>.
III. Letter Review
A. What is the purpose of this Letter Review?
The focus of this Letter Review is to review the quantitative
approach to assessing cancer and non-cancer human health hazards.
Feedback from this review will be considered in the development of Part
2 of the risk evaluation for asbestos.
In addition, EPA intends to publish a separate document, in late
July 2023, in the Federal Register to announce the availability of and
solicit public comment on the white paper, at which time EPA will
provide instructions for submitting written comments
B. Why did EPA develop these documents?
Asbestos was identified as one of the First 10 Chemicals for risk
evaluation under the Toxic Substances Control Act (TSCA) in December
2016. For the purposes of the Risk Evaluation for asbestos under TSCA
section 6(a), EPA initially adopted the TSCA title II (added to TSCA in
1986), section 202 definition; which is ``asbestiform varieties of six
fiber types--chrysotile (serpentine), crocidolite (riebeckite), amosite
(cummingtonite-grunerite), anthophyllite, tremolite or actinolite.''
The latter five fiber types are amphibole varieties. EPA initially
focused its risk evaluation on chrysotile asbestos, as described in the
Problem Formulation for the Risk Evaluation for Asbestos, as this is
the only fiber type with ongoing use, meaning current manufacture,
processing, or distribution in commerce. Following release of this
decision to exclude legacy uses from the risk evaluation, EPA was
legally challenged by Safer Chemicals, Healthy Families, and in late
2019, the court in Safer Chemicals, Healthy Families v. EPA, 943 F.3d
397 (9th Cir. 2019) held that EPA's Risk Evaluation Rule, 82 FR 33726
(July 20, 2017), should not have excluded ``legacy uses'' (i.e., uses
without ongoing or prospective manufacturing, processing, or
distribution) or ``associated disposals'' (i.e., future disposal of
legacy uses) from the definition of conditions of use, although the
court upheld EPA's exclusion of ``legacy disposals'' (i.e., past
disposal). Due to the court ruling, in the March 2020 Draft Risk
Evaluation for Asbestos, EPA had signaled the inclusion of other fiber
types, in addition to chrysotile, as well as consideration of legacy
uses and associated disposal for the asbestos risk evaluation in a
supplemental scope document and supplemental risk evaluation when these
activities are known, intended, or reasonably foreseen. This was
supported by both public comment and the SACC during the SACC Peer
Review (virtual) meeting, June 8-11, 2020. The Risk Evaluation for
Asbestos Part 1: Chrysotile Asbestos was finalized in December 2020,
and specified a Part 2 scope document and risk evaluation would be
forthcoming. The Final Scope of the Risk Evaluation for Asbestos Part
2: Supplemental Evaluation Including Legacy Uses and Associated
Disposals of Asbestos was released in June 2022, taking into
consideration public comment.
In the final scope document for the Part 2 Risk Evaluation, EPA
articulated the plan for the human health analysis to continue to focus
on epidemiologic studies, given the robust evidence base and decades
worth of evidence examining the relationship between exposure to
asbestos and health effects. However, unlike the analysis in Part 1
that was focused on inhalation exposures and cancer, the analysis for
human health in Part 2 considers non-cancer effects and other routes of
exposure. EPA has applied systematic review approach methods, as
described in the Final Scope of the Risk Evaluation for Asbestos Part
2: Supplemental Evaluation Including Legacy Uses and Associated
Disposals of Asbestos and the Draft Systematic Review Protocol
Supporting TSCA Risk Evaluations for Chemical Substances to identify
the reasonably available information to be considered in the Part 2
Risk Evaluation. EPA has continued to screen and evaluate the
epidemiologic evidence following the finalization of the final scope
document in order to determine the specific technical and quantitative
analyses that may be warranted.
[[Page 40821]]
As anticipated, a wealth of epidemiologic evidence was identified,
particularly for inhalation exposures with more limited information for
oral and dermal exposure routes, examining asbestos and cancer and non-
cancer effects. Because the human health hazards are well-established,
it was recognized that streamlined identification of epidemiologic
studies that could inform dose-response would be beneficial. Thus, EPA
employed a fit-for-purpose objective and transparent approach to
efficiently identify and evaluate the relevant information. In
addition, EPA considered the reasonably available information in the
context of the existing EPA assessments and the quantitative risk
values those assessments established: the Risk Evaluation for Asbestos
Part 1: Chrysotile Asbestos (2020) and a chrysotile-specific inhalation
unit risk (IUR) of 0.16 per fiber/cubic centimeter (cc), the Integrated
Risk information System (IRIS) Libby Amphibole Assessment (2017) and a
Libby amphibole-specific IUR of 0.17 per fiber/cc and (Reference
Concentration for Inhalation Exposure (RfC) of 9x10-5 milligram per
cubic meter (mg/m3), and the IRIS Asbestos Assessment (1988) and a
mixed-fiber IUR of 0.23 per fiber/milliliter (mL)). Based on evaluation
and consideration of the totality of the information, EPA has developed
a quantitative approach to assessing cancer and non-cancer human health
hazards for Part 2 of the Risk Evaluation for Asbestos.
EPA is soliciting comments through letter peer review on the
quantitative approach employed to identify the dose-response relevant
information, the evaluation of the epidemiologic cohorts and data for
dose-response assessment, analysis of the existing IURs and RfC and
their potential suitability for application in the Part 2 Risk
Evaluation, and the selection of an IUR and point of departure. EPA has
prepared these technical details in the White Paper on the Quantitative
Human Health Approach to be Applied in the Risk Evaluation for Asbestos
Part 2, for peer-review. Part 2 of the Risk Evaluation will be released
for public comment, anticipated later in 2023 or early 2024, pursuant
to TSCA Section 6.
C. How can I access the documents submitted for review to the peer
reviewers?
EPA is planning to release the white paper mentioned above and all
background documents, related supporting materials, and draft charge
questions by early August 2023. At that time, EPA will publish a
separate document in the Federal Register to announce the availability
of and solicit public comment on the white paper and provide
instructions for submitting written comments. These materials will also
be available in the docket at: <a href="https://www.regulations.gov">https://www.regulations.gov</a> (docket ID
number EPA-HQ-OPPT-2023-0309) and <a href="https://www.epa.gov/tsca-peer-review">https://www.epa.gov/tsca-peer-review</a>.
In addition, as additional background materials become available, EPA
will include those additional background documents (e.g., reviewers
participating in this letter review) in the docket and on the website.
Authority: 15 U.S.C. 2625(o).
Dated: June 16, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-13294 Filed 6-21-23; 8:45 am]
BILLING CODE 6560-50-P
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