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, 40819-40821 [2023-13294]
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Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Notices
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appointment consideration, interested
nominees should submit the application
materials electronically via email to
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the subject line NEYAC, COMMITTEE
APPLICATION PACKAGE 2023 for
(Name of Nominee) by August 22, 2023.
Kathryn Avivah Jakob,
Director, Office of Public Engagement, Office
of Public Engagement and Environmental
Education, Office of the Administrator.
[FR Doc. 2023–13216 Filed 6–21–23; 8:45 am]
BILLING CODE 6560–50–P
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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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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: gibson.tamue@epa.gov.
SUPPLEMENTARY INFORMATION:
DATES:
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: https://www.epa.gov/assessingand-managing-chemicals-under-tsca/
risk-evaluations-existing-chemicalsunder-tsca.
C. Does this action apply to me?
This action is directed to the public
in general. This action may, however, be
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40819
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 https://
www.regulations.gov 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
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40820
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Notices
person making the nomination; name,
affiliation, and contact information for
the nominee; and the disciplinary and
specific areas of expertise of the
nominee.
ddrumheller on DSK120RN23PROD with NOTICES1
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
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18:01 Jun 21, 2023
Jkt 259001
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: https://www.regulations.gov (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:
https://public.govdelivery.com/
accounts/USAEPAOPPT/subscriber/
new?topic_id=USAEPAOPPT_101.
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
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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 noncancer 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.
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Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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 fitfor-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 doseresponse 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
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18:01 Jun 21, 2023
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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:
https://www.regulations.gov (docket ID
number EPA–HQ–OPPT–2023–0309)
and https://www.epa.gov/tsca-peerreview. 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
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–R05–SFUND–2023–0315; FRL–11033–
01–Region 5]
Proposed Prospective Purchaser
Agreement for the Buick City Site in
Flint, Michigan
Environmental Protection
Agency (EPA).
ACTION: Notice; request for public
comment.
AGENCY:
In accordance with the
Prospective Purchaser Agreement,
notice is hereby given of a proposed
administrative settlement concerning
Buick City Site in Flint, Michigan with
the following Settling Party: Flint
Commerce Center, LLC. The settlement
requires the Settling Party to, if
necessary, execute and record a
Declaration of Restrictive Covenant;
provide access to the Site and exercise
due care with respect to existing
contamination. The settlement includes
a covenant not to sue the Settling Party
pursuant to the Comprehensive
Environmental Response,
Compensation, and Liability Act or the
Resource Conservation and Recovery
Act with respect to the Existing
Contamination. Existing Contamination
is defined as any hazardous substances,
pollutants, or contaminants or Waste
Material present or existing on or under
the Property as of the Effective Date of
the Settlement Agreement; any
hazardous substances, pollutants, or
contaminants or Waste Material that
migrated from the Property prior to the
Effective Date; and any hazardous
substances, pollutants, or contaminants
SUMMARY:
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40821
or Waste Material presently at the Site
that migrates onto, on, under, or from
the Property after the Effective Date. For
thirty (30) days following the date of
publication of this notice, the Agency
will receive written comments relating
to the settlement. The Agency will
consider all comments received and
may modify or withdraw its consent to
the settlement if comments received
disclose facts or considerations which
indicate that the settlement is
inappropriate, improper, or inadequate.
The proposed settlement is available for
public inspection at https://
www.regulations.gov. The Agency’s
response to any comments received will
be available for public inspection at the
EPA, Region 5, Records Center, 77 W
Jackson Blvd., 7th Fl., Chicago, Illinois
60604. Commenters may request an
opportunity for a public hearing in the
affected area, in accordance with section
7003(d) of RCRA.
DATES: Comments must be submitted on
or before July 24, 2023.
ADDRESSES: You may send comments,
identified by Docket ID No. EPA–R05–
SFUND–2023–0315, by any of the
following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov/ (our
preferred method). Follow the online
instructions for submitting comments.
• Mail: U.S. Environmental
Protection Agency, ATTN: Mark Koller,
Associate Regional Counsel, Office of
Regional Counsel (C–14J), 77 W Jackson
Blvd., Chicago, Illinois 60604.
Instructions: All submissions received
must include the Docket ID No. for this
rulemaking. Comments received may be
posted without change to https://
www.regulations.gov/, including any
personal information provided. For
detailed instructions on sending
comments and additional information
on the rulemaking process, see the
‘‘Public Participation’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
Mark Koller, Office of Regional Counsel,
Environmental Protection Agency,
telephone number: (312) 353–2591;
email address: koller.mark@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Public Participation
A. Written Comments
Submit your comments, identified by
Docket ID No. EPA–R05–SFUND–2023–
0315, at https://www.regulations.gov
(our preferred method), or the other
methods identified in the ADDRESSES
section. Once submitted, comments
cannot be edited or removed from the
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]]>Agencies
[Federal Register Volume 88, Number 119 (Thursday, June 22, 2023)]
[Notices]
[Pages 40819-40821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13294]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
[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 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:
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca.
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 https://www.regulations.gov 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:
https://www.regulations.gov (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: https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101.
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: https://www.regulations.gov (docket ID
number EPA-HQ-OPPT-2023-0309) and https://www.epa.gov/tsca-peer-review.
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]
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