1,1-Dichloroethane (1,1-DCA); Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Letter Peer Review; Request for Nominations of Expert Reviewers, 20201-20203 [2024-06049]
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Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices
D. Permit Appeals Procedure
Within 120 days following the date
the permit is considered issued for
purposes of judicial review, any
interested person may appeal the permit
decision in the Federal Court of Appeals
in accordance with section 509(b)(1) of
the CWA. Persons affected by a general
permit may not challenge the conditions
of a general permit as a right in further
Agency proceedings. Such person may
instead challenge the general permit in
court, or apply for an individual permit
as specified at 40 CFR 122.21 (and
authorized at 40 CFR 122.28), and then
petition the Environmental Appeals
Board to review any condition of the
individual permit (40 CFR 124.19).
Authority: 33 U.S.C. 1251 et seq.
Toma´s Torres,
Director, Water Division, EPA Region 9.
[FR Doc. 2024–05961 Filed 3–20–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2024–0114; FRL–11809–
01–OCSPP]
1,1-Dichloroethane (1,1-DCA); Draft
Risk Evaluation Under the Toxic
Substances Control Act (TSCA); Letter
Peer Review; Request for Nominations
of Expert Reviewers
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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instructions before submitting that
information.
entities that may be affected by this
action.
The
Peer Review Leader is Alie Muneer,
Mission Support Division (7602M),
Office of Program Support, Office of
Chemical Safety and Pollution
Prevention, Environmental Protection
Agency; telephone number: (202) 564–
6369 or call the main office at (202)
564–8450; email address: muneer.alie@
epa.gov.
SUPPLEMENTARY INFORMATION:
II. Nominations of Peer Reviewers
FOR FURTHER INFORMATION CONTACT:
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 experts for the letter peer
review of the draft risk evaluation for
1,1-DCA. EPA will be soliciting
comments from the experts on the
approach and methodologies utilized in
the draft risk evaluation. This document
provides instructions for submitting
such nominations for EPA to consider
for the planned letter peer review. EPA
will publish a separate document in the
Federal Register in spring 2024 to
announce the availability of the draft
risk evaluation and solicit public
comments. Comments received and the
draft risk evaluation materials will be
provided to the letter peer reviewers in
the summer of 2024.
B. What is the Agency’s authority for
taking this action?
The Environmental Protection
Agency (EPA or the Agency) is seeking
nominations of scientific and technical
experts to review the draft risk
evaluation for 1,1-dichloroethane (1,1DCA) conducted under the Toxic
Substances Control Act (TSCA). The
Agency will release the draft risk
evaluation for public review and
comment in spring of 2024 through a
separate Federal Register document and
subsequently will provide the selected
peer reviewers with the draft risk
evaluation for letter peer review in the
summer of 2024.
DATES: Submit your nominations on or
before April 11, 2024.
ADDRESSES: Submit your nomination via
email to OCSPP-PeerReview@epa.gov.
Do not electronically submit any
information you consider to be
Confidential Business Information (CBI)
or other information whose public
disclosure is restricted by statute. If
your nomination may contain any such
information, please contact the Peer
Review Leader to obtain special
SUMMARY:
20201
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 addressed in 40
CFR part 702 and summarized on EPA’s
website at https://www.epa.gov/
assessing-and-managing-chemicalsunder-tsca/risk-evaluations-existingchemicals-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 and mixtures regulated
under TSCA. Since other entities may
also be interested, the Agency has not
attempted to describe all the specific
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Sfmt 4703
A. Why is EPA seeking nominations for
peer reviewers?
EPA is requesting nominations from
the public and stakeholder communities
for scientific and technical experts who
can serve as prospective candidates for
letter peer reviews. This is part of a
broader process for developing a pool of
candidates. Interested persons or
organizations can nominate qualified
individuals by following the
instructions provided in this document.
Individuals are also welcome to selfnominate.
Those who are selected from the pool
of prospective candidates will be asked
to review the draft risk evaluation for
1,1-DCA and provide their individual
comments to EPA.
B. What expertise is sought for this letter
peer review?
Individuals nominated for this letter
peer review should have expertise in
one or more of the following areas:
1. Environmental hazard assessment
expertise, specifically with experience
in analog selection, predictive
modeling, and uncertainty analysis.
2. Human health toxicology with
expertise in cancer modes of action,
reproductive toxicity and derivation of
points of departure (PODs) and doseresponse values using limited toxicity
datasets.
3. Human health toxicology with
expertise in the use of read across
methodology, the identification of
analog, and the application of read
across software, such as OECD QSAR
Toolbox, GenRA and CompTox.
4. Human exposure assessment
experience, especially for industrial
hygiene and occupational inhalation
exposures, susceptible life stages and
subpopulations to environmental
contaminants.
5. Expertise in using EPA databases
for contaminant concentration estimates
in ambient air and/or surface water and
sediments.
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
submit your nomination via
email to the email identified in
ADDRESSES. Each nomination should
include the following: Contact
DATES,
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Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices
information for the person or entity
making the nomination; name,
affiliation, and contact information for
the nominee; and the disciplinary and
specific areas of expertise of the
nominee.
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D. Will peer 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 peer
reviewers?
The selection of scientists to serve as
peer reviewers is based on the expertise
needed to address the Agency’s charge
to the peer reviewers. No interested
scientists shall be ineligible to serve by
reason of their membership on any
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 peer 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 letter peer 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
peer reviewers. The Agency will
consider all nominations of prospective
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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 approximately
10–12 peer reviewers for this letter peer
review.
EPA plans to make a list of candidates
under consideration as prospective peer
reviewers for this letter peer review
available for public comment by
summer of 2024. The list will be
available in the docket at https://
www.regulations.gov (docket ID number
EPA–HQ–OPPT–2024–0114).
III. Letter Peer Review
A. What is the purpose of this Letter
Peer Review?
The focus of this letter peer review is
to review the approach and
methodologies utilized in the draft risk
evaluation for 1,1-DCA. Feedback from
this review will be considered in the
development of the final 1,1-DCA risk
evaluation.
EPA intends to announce in spring
2024 in the Federal Register, the
availability of and solicit public
comment on the draft risk evaluation, at
which time EPA will provide
instructions for submitting public
comments. The draft risk evaluation and
public comments will be provided to
the letter peer reviewers in the summer
of 2024.
B. Why did EPA develop these
documents?
1,1-DCA was designated in December
2019 as a High-Priority Substance for
risk evaluation under TSCA (84 FR
71924, December 30, 2019 (FRL–10003–
15), and is currently in the risk
evaluation process. In August 2020, the
Agency released the final scope
document outlining the hazards,
exposures, conditions of use, and the
potentially exposed or susceptible
subpopulations the agency expects to
consider in its risk evaluation (85 FR
55281, September 4, 2020 (FRL–10013–
90).
1,1-DCA is a volatile, colorless, oily
liquid with a chloroform-like odor,
which is primarily used in organic
chemical manufacturing. 1,1-DCA is
manufactured and used primarily in
industrial applications, such as a
reactant for the manufacture of other
chemicals or as a laboratory chemical.
The reported total production volume
(PV) of 1,1-DCA in 2015 and 2020 was
between 100 million and 1 billion
pounds. EPA assumes that a high
percentage of the PV is used for
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processing as a reactive intermediate,
and a small percentage of the PV is used
for commercial use as a laboratory
chemical. EPA did not identify any
consumer uses of 1,1-DCA.
The major exposure pathway to 1,1DCA is through releases to air. 1,1-DCA
is estimated to have high water
solubility and once it is released into
water, it remains primarily in the water
column. EPA, therefore, also assessed
relevant surface water and land
exposure pathways. EPA relied on
databases reporting multi-year 1,1-DCA
releases to ambient air, surface water,
and disposal to land, such as the Toxic
Release Inventory (TRI), the National
Emissions Inventory (NEI) and
Discharge Monitoring Reports (DMR),
among others, to conduct major portions
of its exposure analysis. Due to limited
empirical data for human health and
portions of the environmental hazard
assessments, EPA relied on read-across
approaches to supplement 1,1-DCA data
to develop hazard values.
EPA plans to submit the draft risk
evaluation of 1,1-DCA and associated
supporting documents for letter peer
review in the summer of 2024. The draft
risk evaluation includes analyses of
physical-chemical properties; the fate
and transport in the environment;
exposure to workers, and general
population including potentially
exposed or susceptible subpopulations;
releases to the environment;
environmental hazard and risk
characterization for terrestrial and
aquatic species; and human health
hazard and risk characterization for
workers and the general population.
EPA is focusing its letter peer review
charge on specific scientific areas and
analyses and is not developing charge
questions for all aspects of the risk
evaluation. Many of the methods and
analyses used in these evaluations are
not novel and have been reviewed in the
development of the tools used in
various agency work products or in
previous TSCA assessments.
EPA is requesting feedback on novel
approaches, unique exposure analyses
and other calculations, approaches and
results associated with the human
health and environmental hazard
endpoints. Specifically, EPA is seeking
comment on the issues below:
• For human health hazard, EPA has
limited empirical toxicity data available
for 1,1-DCA. EPA has employed an
approach for developing the human
health hazard values through the
utilization of read across to supplement
the 1,1-DCA database using information
from the identified analog, 1,2dichloroethane (1,2-DCA). EPA is
seeking review of the approach for
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Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices
developing the human health hazard
values including the selection and
application of a read across using 1,2DCA as an analog; on the benchmark
response (BMR) for the hazard value
chosen for the human health hazard
value used for the acute, short-term and
chronic exposure durations; and on the
weight of scientific evidence and
confidence for specific hazard
endpoints of central nervous system
(CNS) depression/sedation,
degeneration/necrosis of olfactory
mucosa and decreased sperm
concentration.
• For environmental hazard for
aquatic and benthic organisms, EPA has
limited empirical toxicity data available
for 1,1-DCA and has employed an
approach for developing the
environmental hazard values through
read across using a method for analog
selection. EPA used 1,2-DCA and 1,1,2trichloroethane as analogs to read across
environmental hazard to 1,1-DCA. EPA
is seeking comment on the use of analog
data in combination with 1,1-DCA data
to estimate risk to aquatic vertebrates
and invertebrates, including benthic
invertebrates.
• EPA obtained primary inhalation
exposure monitoring data for 1,1-DCA
for the occupational exposure scenario
(OES) of Manufacture through a test
order and prioritized the use of
occupational inhalation monitoring data
for the intended condition of use and
other appropriate exposure scenarios
(e.g., Processing as a Reactant and
Laboratory Use OESs). EPA is seeking
comment on the use of inhalation
exposure monitoring data for these
analogous exposure scenarios.
• EPA used surrogate chlorinated
solvent inhalation monitoring data to
estimate occupational exposures for the
OES where there was a lack of
inhalation monitoring data and applied
a vapor pressure correction factor to
account for vapor pressure differences
between the surrogate chemical and 1,1DCA. EPA is seeking comments on the
use of surrogate data to estimate
occupational exposures.
• For dermal exposures, EPA lacked
specific 1,1-DCA dermal absorption
data. Therefore, EPA used the Dermal
Exposure to Volatile Liquids Model
(DEVL) and applied the model to all
OES; however, values for fraction
absorbed and weight fraction of the
chemical can differ among OES. EPA is
seeking comments on the application of
DEVL to all OESs and is seeking
methods to better differentiate the
dermal exposure potential and the
resulting risks between OES.
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C. How can I access the documents
submitted for this letter peer review?
EPA is planning to release the draft
risk evaluation for 1,1-DCA, all
background documents and related
supporting materials in the spring of
2024. At that time, EPA will publish a
separate document in the Federal
Register to announce the availability of
and solicit public comment on the
materials and provide instructions for
submitting comments. The materials
will be available in the docket and
through the TSCA Scientific Peer
Review Committees website. In
addition, as additional background
materials become available (e.g., list of
experts participating in this letter peer
review), EPA will include the additional
materials in the docket and through the
website.
Dated: March 14, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2024–06049 Filed 3–20–24; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
[FR ID: 209847]
Privacy Act System of Records
Federal Communications
Commission.
ACTION: Notice of a modified system of
records.
AGENCY:
The Federal Communications
Commission (FCC, Commission, or
Agency) proposes to modify an existing
system of records, FCC/CGB–1, Informal
Complaints, Inquiries, and Requests for
Dispute Assistance, subject to the
Privacy Act of 1974, as amended. This
action is necessary to meet the
requirements of the Privacy Act to
publish in the Federal Register notice of
the existence and character of records
maintained by the agency. The
Commission uses records in this system
to handle and process informal
complaints, inquiries, and requests for
dispute assistance received from
individuals, groups, and other entities.
This modification makes various
necessary changes and updates to
accommodate new uses of the system to
collect and maintain voluntarily
provided demographic data and to
publicly disclose anonymized or deidentified complaint data.
DATES: This modified system of records
will become effective on March 21,
2024. Written comments on the routine
SUMMARY:
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20203
uses are due by April 22, 2024. The
routine uses in this action will become
effective on April 22, 2024 unless
comments are received that require a
contrary determination.
ADDRESSES: Send comments to Brendan
McTaggart, Federal Communications
Commission, 45 L Street NE,
Washington, DC 20554, or privacy@
fcc.gov.
FOR FURTHER INFORMATION CONTACT:
Brendan McTaggart, (202) 418–1738, or
privacy@fcc.gov (and to obtain a copy of
the Narrative Statement and the
Supplementary Document, which
includes details of the proposed
alterations to this system of records).
SUPPLEMENTARY INFORMATION: As
required by the Privacy Act of 1974, as
amended, 5 U.S.C. 552a(e)(4) and
(e)(11), this document sets forth notice
of the proposed modification of a
system of records maintained by the
FCC. The FCC previously provided
notice of the system of records FCC/
CGB–1, Informal Complaints, Inquiries,
and Requests for Dispute Assistance, by
publication in the Federal Register on
September 1, 2023 (88 FR 60459).
This notice serves to update and
modify FCC/CGB–1 to accommodate the
collection and maintenance of
voluntarily provided demographic data
and the public disclosure of
anonymized or de-identified complaint
data. The substantive changes and
modifications to the previously
published version of the FCC/CGB–1
system of records include:
1. Modifying the language in the
Categories of Records to accommodate
the collection and maintenance of
voluntarily provided demographic data.
2. Adding one new routine use: (4)
Public Disclosure of Anonymized
Complaint Data, which will cover the
public disclosure of anonymized or
otherwise de-identified complaint data
in order to promote transparency and
empower third parties to assist the
Commission in identifying trends.
SYSTEM NAME AND NUMBER:
FCC/CGB–1, Informal Complaints,
Inquiries, and Requests for Dispute
Assistance.
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
Consumer and Governmental Affairs
Bureau (CGB), Federal Communications
Commission (FCC), 45 L Street NE,
Washington, DC 20554.
SYSTEM MANAGER(S):
CGB, FCC, 45 L Street NE,
Washington, DC 20554.
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]]>Agencies
[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20201-20203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06049]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2024-0114; FRL-11809-01-OCSPP]
1,1-Dichloroethane (1,1-DCA); Draft Risk Evaluation Under the
Toxic Substances Control Act (TSCA); Letter Peer Review; Request for
Nominations of Expert Reviewers
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
seeking nominations of scientific and technical experts to review the
draft risk evaluation for 1,1-dichloroethane (1,1-DCA) conducted under
the Toxic Substances Control Act (TSCA). The Agency will release the
draft risk evaluation for public review and comment in spring of 2024
through a separate Federal Register document and subsequently will
provide the selected peer reviewers with the draft risk evaluation for
letter peer review in the summer of 2024.
DATES: Submit your nominations on or before April 11, 2024.
ADDRESSES: Submit your nomination via email to [email protected]. Do not electronically submit any information you
consider to be Confidential Business Information (CBI) or other
information whose public disclosure is restricted by statute. If your
nomination may contain any such information, please contact the Peer
Review Leader to obtain special instructions before submitting that
information.
FOR FURTHER INFORMATION CONTACT: The Peer Review Leader is Alie Muneer,
Mission Support Division (7602M), Office of Program Support, Office of
Chemical Safety and Pollution Prevention, Environmental Protection
Agency; telephone number: (202) 564-6369 or call the main office at
(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 experts for
the letter peer review of the draft risk evaluation for 1,1-DCA. EPA
will be soliciting comments from the experts on the approach and
methodologies utilized in the draft risk evaluation. This document
provides instructions for submitting such nominations for EPA to
consider for the planned letter peer review. EPA will publish a
separate document in the Federal Register in spring 2024 to announce
the availability of the draft risk evaluation and solicit public
comments. Comments received and the draft risk evaluation materials
will be provided to the letter peer reviewers in the summer of 2024.
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 addressed in 40 CFR part 702 and summarized on EPA's website
at 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 and mixtures 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.
II. Nominations of Peer Reviewers
A. Why is EPA seeking nominations for peer reviewers?
EPA is requesting nominations from the public and stakeholder
communities for scientific and technical experts who can serve as
prospective candidates for letter peer reviews. This is part of a
broader process for developing a pool of candidates. Interested persons
or organizations can nominate qualified individuals by following the
instructions provided in this document. Individuals are also welcome to
self-nominate.
Those who are selected from the pool of prospective candidates will
be asked to review the draft risk evaluation for 1,1-DCA and provide
their individual comments to EPA.
B. What expertise is sought for this letter peer review?
Individuals nominated for this letter peer review should have
expertise in one or more of the following areas:
1. Environmental hazard assessment expertise, specifically with
experience in analog selection, predictive modeling, and uncertainty
analysis.
2. Human health toxicology with expertise in cancer modes of
action, reproductive toxicity and derivation of points of departure
(PODs) and dose-response values using limited toxicity datasets.
3. Human health toxicology with expertise in the use of read across
methodology, the identification of analog, and the application of read
across software, such as OECD QSAR Toolbox, GenRA and CompTox.
4. Human exposure assessment experience, especially for industrial
hygiene and occupational inhalation exposures, susceptible life stages
and subpopulations to environmental contaminants.
5. Expertise in using EPA databases for contaminant concentration
estimates in ambient air and/or surface water and sediments.
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 via
email to the email identified in ADDRESSES. Each nomination should
include the following: Contact
[[Page 20202]]
information for the person or entity making the nomination; name,
affiliation, and contact information for the nominee; and the
disciplinary and specific areas of expertise of the nominee.
D. Will peer 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 peer reviewers?
The selection of scientists to serve as peer reviewers is based on
the expertise needed to address the Agency's charge to the peer
reviewers. No interested scientists shall be ineligible to serve by
reason of their membership on any 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 peer 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 letter peer
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 peer 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 approximately 10-12 peer reviewers for this
letter peer review.
EPA plans to make a list of candidates under consideration as
prospective peer reviewers for this letter peer review available for
public comment by summer of 2024. The list will be available in the
docket at https://www.regulations.gov (docket ID number EPA-HQ-OPPT-
2024-0114).
III. Letter Peer Review
A. What is the purpose of this Letter Peer Review?
The focus of this letter peer review is to review the approach and
methodologies utilized in the draft risk evaluation for 1,1-DCA.
Feedback from this review will be considered in the development of the
final 1,1-DCA risk evaluation.
EPA intends to announce in spring 2024 in the Federal Register, the
availability of and solicit public comment on the draft risk
evaluation, at which time EPA will provide instructions for submitting
public comments. The draft risk evaluation and public comments will be
provided to the letter peer reviewers in the summer of 2024.
B. Why did EPA develop these documents?
1,1-DCA was designated in December 2019 as a High-Priority
Substance for risk evaluation under TSCA (84 FR 71924, December 30,
2019 (FRL-10003-15), and is currently in the risk evaluation process.
In August 2020, the Agency released the final scope document outlining
the hazards, exposures, conditions of use, and the potentially exposed
or susceptible subpopulations the agency expects to consider in its
risk evaluation (85 FR 55281, September 4, 2020 (FRL-10013-90).
1,1-DCA is a volatile, colorless, oily liquid with a chloroform-
like odor, which is primarily used in organic chemical manufacturing.
1,1-DCA is manufactured and used primarily in industrial applications,
such as a reactant for the manufacture of other chemicals or as a
laboratory chemical. The reported total production volume (PV) of 1,1-
DCA in 2015 and 2020 was between 100 million and 1 billion pounds. EPA
assumes that a high percentage of the PV is used for processing as a
reactive intermediate, and a small percentage of the PV is used for
commercial use as a laboratory chemical. EPA did not identify any
consumer uses of 1,1-DCA.
The major exposure pathway to 1,1-DCA is through releases to air.
1,1-DCA is estimated to have high water solubility and once it is
released into water, it remains primarily in the water column. EPA,
therefore, also assessed relevant surface water and land exposure
pathways. EPA relied on databases reporting multi-year 1,1-DCA releases
to ambient air, surface water, and disposal to land, such as the Toxic
Release Inventory (TRI), the National Emissions Inventory (NEI) and
Discharge Monitoring Reports (DMR), among others, to conduct major
portions of its exposure analysis. Due to limited empirical data for
human health and portions of the environmental hazard assessments, EPA
relied on read-across approaches to supplement 1,1-DCA data to develop
hazard values.
EPA plans to submit the draft risk evaluation of 1,1-DCA and
associated supporting documents for letter peer review in the summer of
2024. The draft risk evaluation includes analyses of physical-chemical
properties; the fate and transport in the environment; exposure to
workers, and general population including potentially exposed or
susceptible subpopulations; releases to the environment; environmental
hazard and risk characterization for terrestrial and aquatic species;
and human health hazard and risk characterization for workers and the
general population.
EPA is focusing its letter peer review charge on specific
scientific areas and analyses and is not developing charge questions
for all aspects of the risk evaluation. Many of the methods and
analyses used in these evaluations are not novel and have been reviewed
in the development of the tools used in various agency work products or
in previous TSCA assessments.
EPA is requesting feedback on novel approaches, unique exposure
analyses and other calculations, approaches and results associated with
the human health and environmental hazard endpoints. Specifically, EPA
is seeking comment on the issues below:
For human health hazard, EPA has limited empirical
toxicity data available for 1,1-DCA. EPA has employed an approach for
developing the human health hazard values through the utilization of
read across to supplement the 1,1-DCA database using information from
the identified analog, 1,2-dichloroethane (1,2-DCA). EPA is seeking
review of the approach for
[[Page 20203]]
developing the human health hazard values including the selection and
application of a read across using 1,2-DCA as an analog; on the
benchmark response (BMR) for the hazard value chosen for the human
health hazard value used for the acute, short-term and chronic exposure
durations; and on the weight of scientific evidence and confidence for
specific hazard endpoints of central nervous system (CNS) depression/
sedation, degeneration/necrosis of olfactory mucosa and decreased sperm
concentration.
For environmental hazard for aquatic and benthic
organisms, EPA has limited empirical toxicity data available for 1,1-
DCA and has employed an approach for developing the environmental
hazard values through read across using a method for analog selection.
EPA used 1,2-DCA and 1,1,2-trichloroethane as analogs to read across
environmental hazard to 1,1-DCA. EPA is seeking comment on the use of
analog data in combination with 1,1-DCA data to estimate risk to
aquatic vertebrates and invertebrates, including benthic invertebrates.
EPA obtained primary inhalation exposure monitoring data
for 1,1-DCA for the occupational exposure scenario (OES) of Manufacture
through a test order and prioritized the use of occupational inhalation
monitoring data for the intended condition of use and other appropriate
exposure scenarios (e.g., Processing as a Reactant and Laboratory Use
OESs). EPA is seeking comment on the use of inhalation exposure
monitoring data for these analogous exposure scenarios.
EPA used surrogate chlorinated solvent inhalation
monitoring data to estimate occupational exposures for the OES where
there was a lack of inhalation monitoring data and applied a vapor
pressure correction factor to account for vapor pressure differences
between the surrogate chemical and 1,1-DCA. EPA is seeking comments on
the use of surrogate data to estimate occupational exposures.
For dermal exposures, EPA lacked specific 1,1-DCA dermal
absorption data. Therefore, EPA used the Dermal Exposure to Volatile
Liquids Model (DEVL) and applied the model to all OES; however, values
for fraction absorbed and weight fraction of the chemical can differ
among OES. EPA is seeking comments on the application of DEVL to all
OESs and is seeking methods to better differentiate the dermal exposure
potential and the resulting risks between OES.
C. How can I access the documents submitted for this letter peer
review?
EPA is planning to release the draft risk evaluation for 1,1-DCA,
all background documents and related supporting materials in the spring
of 2024. At that time, EPA will publish a separate document in the
Federal Register to announce the availability of and solicit public
comment on the materials and provide instructions for submitting
comments. The materials will be available in the docket and through the
TSCA Scientific Peer Review Committees website. In addition, as
additional background materials become available (e.g., list of experts
participating in this letter peer review), EPA will include the
additional materials in the docket and through the website.
Dated: March 14, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-06049 Filed 3-20-24; 8:45 am]
BILLING CODE 6560-50-P
