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
| Published date | 21 March 2024 |
| Record Number | 2024-06049 |
| Citation | 89 FR 20201 |
| Court | Environmental Protection Agency |
| Section | Notices |
Federal Register, Volume 89 Issue 56 (Thursday, March 21, 2024)
[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]
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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.
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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]
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