Initiation of Prioritization Under the Toxic Substances Control Act (TSCA); Notice of Availability, 102903-102908 [2024-29829]
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Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices
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IV. Designation as High-Priority
Substances for Risk Evaluation
Based on the information provided in
the proposed designation documents, as
referenced in the document that
appeared in the Federal Register of July
25, 2024 (Ref. 2), and public comments
received, including information
pertaining to individual chemical
substances, EPA is designating the same
five chemicals as High-Priority
Substances for risk evaluation under
TSCA. Pursuant to 40 CFR 702.11,
which states: ‘‘For High-Priority
Substances, EPA generally expects to
indicate which condition(s) of use were
the primary basis for such
designations.’’ For all five High-Priority
Substances the conditions of use which
formed the primary basis for the
designation were included in the
proposed designation documents. The
final High-Priority Substance
designations are as follows:
• Acetaldehyde, CASRN 75–07–0,
Docket ID number: EPA–HQ–OPPT–
2018–0497;
• Acrylonitrile, CASRN 107–13–1,
Docket ID number: EPA–HQ–OPPT–
2018–0449;
• Benzenamine, CASRN 62–53–3,
Docket ID number: EPA–HQ–OPPT–
2018–0474;
• Vinyl chloride, CASRN 75–01–4,
Docket ID number: EPA–HQ–OPPT–
2018–0448; and
• 4,4′-Methylene bis(2-chloroaniline)
(MBOCA), CASRN 101–14–4, Docket ID
number: EPA–HQ–OPPT–2018–0464.
The final designations are based on
the conclusion that each chemical
substance satisfies the definition of
High-Priority Substance in TSCA
section 6(b)(1)(B) and 40 CFR 702.3.
EPA developed a document for each
substance to identify the information,
analysis and basis used to support the
proposed designations as a High-Priority
Substance for risk evaluation. These
documents are available in the docket of
each of the chemical substances. Also
included in each document is an
explanation of the approach used by
EPA to conduct the review. Each
document includes an overview of the
requirements in TSCA section 6(b)(1)(A)
and a regulatory section addressing the
review criteria and considerations (40
CFR 702.9).
These designated High-Priority
Substances will fulfill the statutory
requirement to designate at least one
high-priority substance upon
completion of each risk evaluation for a
High-Priority Substance, under TSCA
section 6(b)(3)(C). Pursuant to TSCA
section 6(b)(3)(A) and 40 CFR 702.17,
the designation of these chemical
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substances as High-Priority Substances
constitutes the initiation of the risk
evaluations on the substances.
A designation of a chemical substance
as a High-Priority Substance is not a
finding of unreasonable risk; rather, a
final designation as a High-Priority
Substance initiates the risk evaluation
for the chemical substance. This is a
three-year process that will culminate in
a finding of whether or not the chemical
substance presents an unreasonable risk
of injury to health or the environment
under the conditions of use. The
chemical-specific designation
documents containing the information,
analysis and basis used to support the
proposed designations are located in the
docket for each chemical substance. As
previously discussed, to the extent that
comments provided information on
additional conditions of use for the
candidate High-Priority Substances for
risk evaluation, those conditions of use
were noted in the proposed designation
documents for each chemical substance
and may be reflected in the draft scope
of the risk evaluation for each chemical
substance, which will include the
conceptual model and analysis plan for
carrying out the evaluation. As such,
EPA will not amend the proposed
designation documents. Instead,
additional submitted potentially
relevant information specific to HighPriority Substances (e.g., relevant
studies and assessments) will be
considered in subsequent phases of risk
evaluation, including draft scope
documents and draft risk evaluation
documents, both of which will be
subject to public comment
opportunities.
V. References
The following is a listing of the
documents that are specifically
referenced in this document. The docket
for this action includes these documents
and other information considered by
EPA, including documents that are
referenced within the documents that
are included in the docket. For
assistance in locating these referenced
documents, please consult the technical
person listed under FOR FURTHER
INFORMATION CONTACT.
1. EPA. Initiation of Prioritization Under the
Toxic Substances Control Act (TSCA).
Notice. Federal Register. 88 FR 87423,
December 18, 2023 (FRL–11581–01–
OCSPP).
2. EPA. Proposed High-Priority Substance
Designations Under the Toxic
Substances Control Act (TSCA). Federal
Register. 89 FR 60420, July 25, 2024
(FRL–11581–03–OCSPP).
3. EPA. EPA Response to Public Comments
Received on the ‘‘Initiation of
Prioritization Under the Toxic
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Substances Control Act’’ and ‘‘Proposed
High-Priority Substance Designations
Under the Toxic Substances Control
Act.’’ December 18, 2024.
4. EPA. ‘‘A Working Approach for Identifying
Potential Candidate Chemicals for
Prioritization.’’ (https://www.epa.gov/
sites/production/files/201809/
documents/preprioritization_white_
paper_9272018.pdf). September 27,
2018.
Authority: 15 U.S.C. 2601 et seq.
Dated: December 12, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2024–29830 Filed 12–17–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2023–0601; FRL–11581–
06–OCSPP]
Initiation of Prioritization Under the
Toxic Substances Control Act (TSCA);
Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
Under the Toxic Substances
Control Act (TSCA) and related
implementing regulations, EPA is
initiating the prioritization process for
five chemical substances as candidates
for designation as High-Priority
Substances for risk evaluation. This
action provides the identity of the
chemical substances being initiated for
prioritization, a general explanation of
why the Agency chose these chemical
substances, and information on the data
sources EPA plans to use to support the
designation. EPA is providing a 90-day
comment period, during which
interested persons may submit relevant
information on these chemical
substances.
DATES: Comments must be received on
or before March 18, 2025.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number, through https://
www.regulations.gov. Follow the online
instructions for submitting comments.
For comments not related to a specific
chemical, including general comments
on Unit IV.A., use docket ID number
EPA–HQ–OPPT–2023–0601; submit
information on the candidates for which
EPA is initiating the prioritization
process to the applicable chemicalspecific docket ID number identified in
Unit III.B.; submit information on the
potential candidates for which EPA is
not currently initiating the prioritization
SUMMARY:
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Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices
process to the docket ID number
identified in Unit IV.B. Do not submit
electronically any information you
consider to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Sarah Au,
Data Gathering, Management, and
Policy Division (7406M), Office of
Pollution Prevention and Toxics,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
564–0398; email address: au.sarah@
epa.gov.
For general information: The TSCAHotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620;
telephone number: (202) 554–1404;
email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
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A. Does this action apply to me?
This action is directed to the public
in general and may be of interest to
entities that currently or may
manufacture (including import) a
chemical substance regulated under
TSCA (e.g., entities identified under
North American Industrial
Classification System (NAICS) codes
325 and 324110). The action may also
be of interest to chemical processors,
distributors in commerce, users, nonprofit organizations in the
environmental and public health
sectors, state and local government
agencies, Tribes, and members of the
public. Because other entities may also
be interested, the Agency has not
attempted to describe all the specific
entities and corresponding NAICS codes
for entities that may be interested in or
affected by this action.
B. What action is the Agency taking?
EPA is initiating the prioritization
process under TSCA, 15 U.S.C. 2601 et
seq., for five chemical substances as
candidates for designation as HighPriority Substances for risk evaluation.
This document includes the identity of
the chemical substances entering the
prioritization process before designation
and a general explanation of why the
Agency chose to initiate prioritization
on these chemical substances. In
addition, EPA is providing a 90-day
comment period during which
interested persons may submit relevant
information on these chemical
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substances. Relevant information might
include, but is not limited to, any
information that may inform the
prioritization screening review
conducted pursuant to 40 CFR 702.9(a).
C. Why is the Agency taking this action?
TSCA section 6(b) requires that EPA
initiate the prioritization process for
chemical substances that may be
designated as high priority or low
priority for risk evaluation. Because
EPA generally expects to complete five
risk evaluations per year over the next
several years, EPA is initiating the
prioritization process for five chemical
substances per TSCA section 6(b)(3)(C),
which requires EPA to designate at least
one High-Priority Substance upon
completion of each risk evaluation for a
High-Priority Substance. In the Federal
Register on December 18, 2023 (88 FR
87423) (FRL–11581–01–OCSPP)), EPA
initiated prioritization for five chemical
substances that have undergone
consideration as High-Priority
Substances pursuant to TSCA section
6(b)(2)(B). By initiating prioritization
another five chemical substances
pursuant to TSCA section 6(b)(2)(B),
EPA intends to maintain a sustainable
pipeline of existing chemical risk
evaluations under TSCA section 6(b).
The request for interested persons to
submit relevant information on a
chemical substance for which EPA has
initiated the prioritization process is
required by TSCA section 6(b)(1)(C)(i).
D. What is the Agency’s authority for
taking this action?
This document is issued pursuant to
the authority in TSCA section 6(b)(1)
and (3)(C).
E. What are the estimated incremental
impacts of this action?
This document does not establish
requirements on persons or entities
outside of the Agency. No incremental
impacts are therefore anticipated, and
consequently EPA did not estimate
potential incremental impacts for this
action.
F. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through
https://www.regulations.gov or email. If
you wish to include CBI in your
comment, please follow the applicable
instructions at https://www.epa.gov/
dockets/commenting-epa-dockets#rules
and clearly mark the part or all the
information you claim to be CBI. In
addition to one complete version of the
comment including information claimed
as CBI, a copy of the comment that does
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not contain the information claimed as
CBI must be submitted for inclusion in
the public docket. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2 and/or 40 CFR part 703,
as applicable.
2. Tips for Preparing Your Comments
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
commenting-epa-dockets.html.
II. Background
TSCA section 6(b)(1) requires EPA to
prioritize chemical substances for risk
evaluation and to establish a process for
prioritizing chemical substances. Under
TSCA section 6(b) and as described in
40 CFR 702.7, EPA is initiating the
prioritization process for five chemical
substances as candidates for HighPriority Substances for risk evaluation.
Under TSCA section 6(b)(1)(B) and its
implementing regulations (40 CFR
702.3), a High-Priority Substance is
defined as a chemical substance that
EPA determines, without consideration
of costs or other non-risk factors, may
present an unreasonable risk of injury to
health or the environment because of a
potential hazard and a potential route of
exposure under the conditions of use,
including an unreasonable risk to
potentially exposed or susceptible
subpopulations identified as relevant by
EPA.
Initiation of prioritization for
chemical substances as High-Priority
Substance candidates is not a finding of
risk. Rather, when prioritization is
complete, for those chemicals
designated as High-Priority Substances,
EPA will have evidence that this
substance may present an unreasonable
risk of injury to health or the
environment because of a potential
hazard and a potential route of exposure
under the conditions of use. Final
designation of a High-Priority Substance
initiates the risk evaluation process (40
CFR 702.17), which culminates in a
finding of whether the chemical
substance presents an unreasonable risk
under the conditions of use.
This document is intended to fulfill
the TSCA section 6(b)(1)(C)(i)
requirement that the Administrator
request interested persons to submit
relevant information on chemical
substances for which the Administrator
has initiated the prioritization process.
As described in 40 CFR 702.7, this
document initiates the prioritization
process and provides 90 days during
which interested persons may submit
relevant information.
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As described in 40 CFR 702.9(b), in
conducting the screening review during
the prioritization process, EPA will
consider sources of information relevant
to the screening review criteria as
outlined in the statute (TSCA section
6(b)(1)(A)) and implementing
regulations (40 CFR 702.9(a)) and
consistent with the scientific standards
of TSCA section 26(h), including, as
appropriate, sources for hazard and
exposure data listed in Appendices A
and B of the TSCA Work Plan
Chemicals: Methods Document
(February 2012).
Consistent with the approach
described in 40 CFR 702.7, and the ‘‘A
Working Approach for Identifying
Potential Candidate Chemicals for
Prioritization’’ document (September
27, 2018), available at https://
www.epa.gov/sites/default/files/201809/documents/preprioritization_white_
paper_9272018.pdf, EPA consulted with
other federal agencies and intends to
continue to collaborate with them to
identify information that is useful
throughout the prioritization process.
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III. High Priority Candidate Chemical
Substances for Which EPA Is Initiating
Prioritization
A. How did EPA select these candidates
for prioritization for potential
designation as High-Priority Substances
for risk evaluation?
In general, EPA’s working approach to
select candidates for designation as
High-Priority Substances for risk
evaluation is outlined in the document,
titled ‘‘A Working Approach for
Identifying Potential Candidate
Chemicals for Prioritization,’’ released
to the public on September 27, 2018,
available at https://www.epa.gov/sites/
default/files/2018-09/documents/
preprioritization_white_paper_
9272018.pdf. To identify candidates for
designation as High-Priority Substances,
EPA primarily reviewed the ‘‘TSCA
Work Plan for Chemical Assessments:
2014 Update (2014 TSCA Work Plan),’’
available at https://www.epa.gov/
assessing-and-managing-chemicalsunder-tsca/tsca-work-plan-chemicalassessments-2014-update. TSCA
requires EPA to preferentially consider
chemicals on the 2014 TSCA Work Plan
that are persistent and bioaccumulative
and those that are known human
carcinogens and highly toxic, based on
scores and criteria documented in the
Work Plan, as these chemicals were
selected for inclusion on the Work Plan
due to their potential risk to human
health and the environment. Aside from
this statutory requirement, TSCA gives
EPA discretion in how the Agency
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ultimately selects a chemical substance
for prioritization. EPA strives to
designate as High-Priority Substances
those chemicals with the greatest hazard
and exposure potential first, consistent
with the policy objectives codified in 40
CFR 702.5(a) in the Federal Register on
July 20, 2017 (82 FR 33753) (FRL–9964–
24)).
The number of chemical substances
remaining on the 2014 TSCA Work Plan
with persistence and bioaccumulation
scores of 3 has been significantly
reduced over time as EPA has expedited
rulemaking under TSCA section 6(h) for
five persistent, bioaccumulative, and
toxic (PBT) chemical substances and as
the Agency has conducted risk
evaluations and promulgated risk
management for rules for other chemical
substances from the 2014 TSCA Work
Plan. TSCA section 6(b)(2)(B) further
requires that at least 50 percent of all
ongoing risk evaluations be drawn from
the 2014 TSCA Work Plan for Chemical
Assessments. Given EPA’s statutory
deadlines and the timing of
prioritization actions needed to offset
the completion of risk evaluations for
chemical substances designated as HighPriority Substances in 2019, EPA
heavily weighed data availability in
deciding which chemical substances to
include in this action. Chemical
substances remaining on the 2014 TSCA
Work Plan that have persistence and
bioaccumulation scores of 3 have
significant data gaps, were submitted as
potential manufacturer-requested risk
evaluation candidates or are categories
for which EPA is in the process of
determining specific chemical
structures that may be considered for
inclusion in those categories.
EPA consulted with other EPA
program offices and partner federal
agencies to inform the Agency’s
prioritization efforts. With these
considerations, the chemicals for which
prioritization is initiated in this action
were selected based on a variety of
factors and reflect Agency priorities.
While data availability was a significant
driver of the Agency’s selections, EPA
also considered the complexity of
evaluating broad chemical categories
such as metal compounds. For EPA to
build a sustainable TSCA prioritization,
evaluation, and (when appropriate) risk
management pipeline, chemicals
ultimately designated as High-Priority
Substances for risk evaluation should
have a robust data landscape. In future
rounds of prioritization, EPA intends to
use its data gathering authorities earlier
and commits to regular stakeholder
engagement to ensure the Agency has
the information needed to meet its
statutory mandates.
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Using data sources such as those
described in the document titled, ‘‘A
Working Approach for Identifying
Potential Candidate Chemicals for
Prioritization,’’ EPA considered various
types of information and data from
existing resources such as EPA’s
National Center for Computational
Toxicology’s Chemistry Dashboard
(CompTox Chemicals Dashboard),
available at https://comptox.epa.gov/
dashboard. EPA also conducted initial
searches of additional sources of public
and gray literature (e.g., PubMed, Web
of Science, other U.S. government and
international websites).
EPA also considered existing
information from public and non-public
(i.e., confidential business information)
sources maintained by authoritative
sources, such as other EPA program
offices, state and federal agencies, and
various U.S. and international
organizations (including but not limited
to EPA’s Office of Water, EPA’s Office
of Air and Radiation, EPA’s Office of
Research and Development, California
Environmental Protection Agency,
National Institute for Occupational
Safety and Health, Agency for Toxic
Substances and Disease Registry,
European Chemicals Agency, Health
Canada, International Agency for
Research on Cancer, and Organisation
for Economic Co-operation and
Development).
After identifying information from
reasonably available sources, the
information was screened across several
data elements including physical and
chemical properties, environmental fate
and transport properties, hazard,
exposure, and use information to
determine the breadth of data
availability for a chemical substance.
Using experience gained from TSCA
implementation activities to date, EPA
considered previous and planned
Agency activities related to a given
chemical substance, including how to
better leverage experience gained from
previously conducted or ongoing risk
evaluations. EPA also considered
whether analyses from previous risk
assessments could be used to better
understand each chemical substance’s
potential exposure and/or hazard
characteristics.
In the absence of measured empirical
data on chemicals being evaluated, EPA
may use alternative means or new
approach methods (NAMs) to obtain
relevant data. NAMs can reduce
vertebrate testing, consistent with TSCA
section 4(h)(1)(A). EPA intends to use
this approach to the extent practicable
and scientifically justified.
EPA also considered information such
as data submitted to EPA in 2020 under
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the Chemical Data Reporting (CDR) rule
under TSCA regarding reported uses
and products to inform prioritization
and risk evaluation. EPA considered the
use information for these chemicals and
screened them according to the types of
industrial uses and types of products for
which the chemicals were used as
reported in the 2020 CDR. Information
reported to the Toxics Release Inventory
Program was also considered to identify
reported uses and releases of chemical
substances.
EPA intends to update and refine its
initial review based on data sources
identified by the public during the
comment period (see EPA’s request for
data in Unit IV.) and, as permitted by
TSCA section 14 and subject to EPA
confidentiality regulations at 40 CFR
part 2, subpart B and 40 CFR part 703,
intends to make this information
publicly available for the initiated
chemicals when EPA publishes the
proposed priority designation.
Between December 18, 2023, and
October 31, 2024, EPA received
information regarding candidate
chemical substances being considered
for prioritization actions during two
periods. During September and October
2023, EPA hosted a series of preprioritization meetings with various
stakeholders, Tribes, state and local
governments, and other federal agencies
to explain the prioritization process and
provide an overview of information that
may be used to inform the
considerations that ultimately support a
High- or Low-Priority Substance
designation. A list of 15 candidate
chemical substances being considered
for future prioritization actions,
including those undergoing initiation in
this prioritization action, was presented
to provide an opportunity for partners,
stakeholders, and any interested persons
to comment on the data and scientific
literature available that may be used to
help EPA determine which chemical
substances may undergo prioritization
in the near term. EPA also opened
docket ID No. EPA–HQ–OPPT–2023–
0606 for 90 days to receive any
potentially relevant information on the
10 chemical substances communicated
as candidates for prioritization but not
selected for initiation on December 18,
2023, which included the chemical
substances for which prioritization is
being initiated with this action.
As a part of EPA’s commitment to
greater transparency and to maintain
engagement with partners, stakeholders
or any interested persons about
upcoming prioritization actions, EPA
hosted public webinars on September
30 and October 1, 2024, that explained
the prioritization process, provided an
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overview of information that may be
used to inform the considerations that
ultimately support a High- or LowPriority Substance designation, and
shared an expanded list of 27 candidate
chemical substances being considered
for prioritization actions. This expanded
list included the 10 chemical substances
previously communicated in 2023 as
being potential candidates for
prioritization but not yet selected for
initiation. Following the public
webinars, EPA opened docket ID No.
EPA–HQ–OPPT–2023–0606 for 30 days
to receive any potentially relevant
information on the 27 chemical
substances communicated as being
candidates for prioritization. EPA also
engaged with Tribes, state and local
governments, and other federal agencies
and presented the same information that
was provided during the public
webinars.
EPA considered all comments and
information received during the various
meetings and webinars, as well as those
submitted to docket ID no. EPA–HQ–
OPPT–2023–0606 on all candidate
chemical substances considered for
prioritization actions communicated
between September 2023 and October
2024 to identify the five chemical
substances being initiated for
prioritization. During the first 90-day
public comment period accompanying
the initiation action that began in
December 2023, EPA received
comments pertaining to six chemical
substances communicated as potential
candidates for prioritization during the
pre-prioritization presentations in
September and October 2023 and
September and October 2024: 4-tertoctylphenol, N-(1,3-Dimethylbutyl)-N′phenyl-p-phenylenediamine (6PPD),
benzene, ethylbenzene, naphthalene,
and styrene.
One commentor (EPA–HQ–OPPT–
2018–0448–0027) wrote in general
support of the consideration of benzene,
ethylbenzene, naphthalene, and styrene
for upcoming prioritization actions and
the consideration of submitted
information on natural disasters and
environmental impacts on potential
exposure.
Some commenters (EPA–HQ–OPPT–
2023–0606–0005; EPA–HQ–OPPT–
2023–0606–0006; EPA–HQ–OPPT–
2023–0606–0007) included information
on 6PPD and/or 6PPD-quinone (a
degradation product of 6PPD) for
consideration in upcoming
prioritization actions and in support of
the petition submitted under TSCA
section 21 requesting the promulgation
of risk management regulations under
TSCA section 6(a) to prohibit the
manufacturing, processing, use and
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distribution of 6PPD for and in tires to
eliminate unreasonable risk to the
environment.
Another commenter (EPA–HQ–
OPPT–2023–0606–0005) requested that
docket ID. No. EPA–HQ–OPPT–2023–
0606 remain open to allow for
continuous submission of potentially
relevant information regarding the
characterization of 6PPD risk. EPA
intends to re-open docket ID No. EPA–
HQ–OPPT–2023–0606 during specific
timeframes during pre-prioritization to
allow for submission of information
using regulations.gov.
As described in Unit IV.B., EPA is
also re-opening docket ID No. EPA–HQ–
OPPT–2023–0606 to solicit comments
and information on 22 chemical
substances that are candidates for future
prioritization actions. Regarding the
TSCA section 21 petition from
Earthjustice on behalf of the Yurok
Tribe, the Port Gamble S’Klallam Tribe,
and the Puyallup Tribe of Indians, EPA
issued an Advance Notice of Proposed
Rulemaking in the Federal Register on
November 18, 2024 (89 FR 91299) (FRL–
11682–01–OCSPP)) for 6PPD and 6PPDquinone under TSCA section 6(a), and
is committed to finalizing a TSCA
section 8(d) rulemaking by the end of
2024 that would require persons who
manufacture (including import) 6PPD to
submit lists or copies of unpublished
health and safety studies to EPA.
One commentor (EPA–HQ–OPPT–
2023–0606–0003) stated that the
information presented in the 2014 TSCA
Work Plan was incorrect for 4-tertoctylphenol and that EPA should not
include 4-tert-octylphenol on the fourth
Candidate Chemical List under SDWA.
Under TSCA, EPA is required to
consider chemical substances identified
in the 2014 TSCA Work Plan and does
not plan to revise the Work Plan as part
of this action. Additional information
received regarding the potential hazard,
potential exposure, and
bioaccumulation and persistence of 4tert-octylphenol may be considered
during prioritization.
For more information on the
comments and EPA’s responses
regarding the candidate chemical
substances, see Section 1.7 and 7.1 of
the ‘‘EPA Response to Public Comments
Received on the ‘‘Initiation of
Prioritization Under the Toxic
Substances Control Act’’ and ‘‘Proposed
High-Priority Substance Designations
Under the Toxic Substances Control
Act’’ document published in docket ID
no. EPA–HQ–OPPT–2023–0601 and
EPA–HQ–OPPT–2023–0606.
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B. What chemicals are being initiated?
EPA is initiating the prioritization
process for the following five chemicals
as candidates for designation as HighPriority Substances:
1. 4-Tert-Octylphenol, CASRN 140–66–
9, Docket ID No.: EPA–HQ–OPPT–
2018–0496
This chemical was listed in the 2014
TSCA Work Plan with a hazard score of
3; an exposure score of 3; and a
persistence and bioaccumulation score
of 2. Exposure to 4-tert-octyphenol (4(1,1,3,3-tetramethylbutyl)-phenol may
result in a range of human health effects
such as kidney inflammation and
impaired fertility (i.e., lowered sperm
count). Data related to human
carcinogenicity have not been
identified. Data regarding the use of this
chemical was reported to EPA in the
2020 CDR. EPA also receives
information annually on this chemical
through the Toxics Release Inventory
(TRI). Information is available from
assessments conducted by international
organizations, and other countries.
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2. Benzene, CASRN 71–43–2, Docket ID
No.: EPA–HQ–OPPT–2018–0475
This chemical was listed in the 2014
TSCA Work Plan with a hazard score of
3; an exposure score of 3; and a
persistence and bioaccumulation score
of 1. Data regarding the use of this
chemical was reported to EPA in the
2020 CDR. Benzene is a known human
carcinogen. Exposure to benzene may
also result in a range of health effects
such as immune function (e.g.,
decreased immune lymphocyte count)
and developmental abnormalities (i.e.,
fetal malformations). EPA also receives
information annually on this chemical
through the TRI. Information is
available from assessments conducted
by other federal agencies, the state of
California, international organizations,
and other countries.
3. Ethylbenzene, CAS RN 100–41–4,
Docket ID No.: EPA–HQ–OPPT–2018–
0487
This chemical was listed in the 2014
TSCA Work Plan with a hazard score of
3; an exposure score of 3; and a
persistence and bioaccumulation score
of 1. Ethylbenzene is a probable human
carcinogen. Exposure to ethylbenzene
may also result in a range of health
effects such as changes to liver and
kidney tissue, hearing loss, and
developmental abnormalities (i.e., fetal
malformations). Data regarding the use
of this chemical was reported to EPA in
the 2020 CDR. EPA also receives
information annually on this chemical
through the TRI. Information is
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available from assessments conducted
by other federal agencies, the state of
California, international organizations,
and other countries.
4. Naphthalene, CASRN 91–20–3,
Docket ID No.: EPA–HQ–OPPT–2018–
0454
This chemical was listed in the 2014
TSCA Work Plan with a hazard score of
3; an exposure score of 3; and a
persistence and bioaccumulation score
of 2. Naphthalene is a probable human
carcinogen. Exposure to naphthalene
may also result in a range of health
effects such as destruction of red blood
cells resulting in lower blood oxygen,
damage to eyesight, and changes to
liver, lung, and nasal tissue. Data
regarding the use of this chemical was
reported to EPA in the 2020 CDR. EPA
also receives information annually on
this chemical through the TRI.
Information is available from
assessments conducted by other federal
agencies, the state of California,
international organizations, and other
countries.
5. Styrene, CASRN 100–42–5, Docket ID
No.: EPA–HQ–OPPT–2018–0461
This chemical was listed in the 2014
TSCA Work Plan with a hazard score of
3; an exposure score of 3; and a
persistence and bioaccumulation score
of 1. Styrene is a probable human
carcinogen. Exposure to styrene may
also result in a range of health effects
such as hearing loss, memory loss, fetal
death, and tissue changes in the lungs
and nasal passages. Data regarding the
use of this chemical was reported to
EPA in the 2020 CDR. EPA also receives
information annually on this chemical
through the TRI. Information is
available from assessments conducted
by other federal agencies, the state of
California, international organizations,
and other countries.
IV. Relevant Information
A. What additional information is EPA
seeking for the five candidate chemical
substances for which EPA is initiating
prioritization?
Through this initiation of
prioritization for chemical substances,
EPA is providing a 90-day comment
period as required by the statute (TSCA
section 6(b)(1)(C)(i)) and implementing
regulations (40 CFR 702.7(d)) and
requesting that interested persons
voluntarily submit relevant information.
Relevant information might include, but
is not limited to, information that may
inform the screening review conducted
pursuant to 40 CFR 702.9(a), consistent
with the scientific standard of TSCA
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section 26(h), about the following
criteria and considerations:
• The chemical substance’s hazard
and exposure potential;
• The chemical substance’s
persistence and bioaccumulation;
• Potentially exposed or susceptible
subpopulations which the submitter
believes are relevant to the
prioritization;
• Whether there is any storage of the
chemical substance near significant
sources of drinking water, including the
storage facility location and the nearby
drinking water source(s);
• The chemical substance’s
conditions of use or significant changes
in conditions of use, including
information regarding trade names;
• The chemical substance’s
production volume or significant
changes in production volume; and
• Any other information relevant to
the potential risks of the chemical
substance that might be relevant to the
designation of the chemical substance’s
priority for risk evaluation.
If the information is publicly
available, citations are sufficient
(including, but not limited to: Title,
author, date of publication, publication
source), and the submission does not
need to include copies of the
information.
B. What information is the Agency
seeking for the 22 additional chemical
substances that EPA considered, but did
not select, for the current round of
prioritization?
During the pre-prioritization process,
EPA hosted public webinars and met
with federal partners, industry,
environmental organizations, labor
organizations, state and local
governments, and Tribes to discuss the
prioritization process and presented a
list of 27 chemical substances EPA was
considering for prioritization. EPA took
feedback from these discussions into
consideration when selecting the five
chemicals for prioritization listed in
Unit III.B. Interested persons may
submit relevant information on the
chemical substances listed in this unit
that are not currently undergoing
prioritization by using docket ID
number EPA–HQ–OPPT–2023–0606.
EPA has not yet determined which
specific chemical structures are being
considered for the chemical substances
designated as a category in the 2014
TSCA Work Plan (i.e., do not have
CASRN listed). Therefore, EPA
welcomes comments and information
on specific chemical structures that may
be relevant for addressing the various
prioritization criteria and considerations
on the chemical categories listed in this
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unit. Information submitted on the
substances within a category should be
reported for each individual chemical
structure, to the extent possible (i.e.,
known or reasonably ascertainable). If
the chemical identity of some of the
individual chemical structures are not
known or reasonably ascertainable by
the commenter, the information
associated with those chemical
substances may be reported as a group
of chemical structures (i.e., isomeric
mixture) or as the chemical category:
• 1-Hexadecanol, CASRN 36653–82–
4;
• 2-Ethylhexyl 2,3,4,5tetrabromobenzoate (TBB), CASRN
183658–27–7;
• Bis(2-Ethylhexyl)-3,4,5,6Tetrabromophthalate (TBPH), CASRN
26040–51–7;
• Bisphenol A, CASRN 80–05–7;
• Creosote, CASRN 8001–58–9;
• Di-n-octyl phthalate (DnOP),
CASRN 117–84–0;
• N-Nitroso-diphenylamine, CASRN
86–30–6;
• P,P′Oxybis(benzenesulfonylhydrazide),
CASRN 80–51–3;
• Tribromomethane, CASRN 75–25–
2;
• Triglycidyl isocyanurate, CASRN
2451–62–9;
• M-Xylene, CASRN 108–38–3;
• O-Xylene, CASRN 95–47–6;
• P-Xylene, CASRN 106–42–3;
• Antimony and Antimony
Compounds, Category;
• Arsenic and Arsenic Compounds,
Category;
• Cobalt and Cobalt Compounds,
Category;
• Lead and Lead Compounds,
Category;
• Long-chain chlorinated paraffins
(C18-20), Category;
• Medium-chain chlorinated paraffins
(C14-17), Category;
• Bisphenol S, CASRN 80–09–1;
• Hydrogen Fluoride, CASRN 7664–
39–3;
• N-(1,3-Dimethylbutyl)-N′-phenyl-pphenylenediamine (6PPD), CASRN 793–
24–8.
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C. How will confidential business
information be protected?
A person seeking to protect from
disclosure as ‘‘confidential business
information’’ any information that
person submits under TSCA must assert
and substantiate a claim for protection
from disclosure concurrent with
submission of the information in
accordance with the requirements of
TSCA section 14 and 40 CFR 703, with
limited exceptions provided in the
statute. TSCA section 14(b) limits
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confidentiality protections for health
and safety studies and information from
such studies, however, and while EPA
considers confidential business
information when conducting its review
under 40 CFR 702.9(a), the Agency
encourages submitters to minimize
claims for protection from disclosure
wherever possible to maximize
transparency in EPA’s screening review.
More information on asserting and
submitting confidential business
information claims under TSCA can be
found at 40 CFR 703 and https://
www.epa.gov/tsca-cbi.
Authority: 15 U.S.C. 2601 et seq.
Dated: December 12, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2024–29829 Filed 12–17–24; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL ELECTION COMMISSION
Sunshine Act Meetings
FEDERAL REGISTER CITATION NOTICE OF
PREVIOUS ANNOUNCEMENT: 89 FR 89012.
PREVIOUSLY ANNOUNCED TIME AND DATE OF
THE MEETING: Thursday, November 14,
2024 at 11:00 a.m., Hybrid Meeting:
1050 First Street NE, Washington, DC
(12th Floor) and virtual.
CHANGE IN THE MEETING: The November
14, 2024 Open Meeting was canceled.
CONTACT PERSON FOR MORE INFORMATION:
Judith Ingram, Press Officer. Telephone:
(202) 694–1220.
(Authority: Government in the Sunshine Act,
5 U.S.C. 552b)
Laura E. Sinram,
Secretary and Clerk of the Commission.
[FR Doc. 2024–30107 Filed 12–16–24; 11:15 am]
BILLING CODE 6715–01–P
FEDERAL RESERVE SYSTEM
[Docket No. OP–1863]
Regulation Q; Regulatory Capital Rule:
Risk-Based Capital Surcharges for
Global Systemically Important Bank
Holding Companies
Board of Governors of the
Federal Reserve System (Board).
ACTION: Notice.
AGENCY:
The Board is providing notice
of the 2024 aggregate global indicator
amounts, as required under the Board’s
rule regarding risk-based capital
surcharges for global systemically
important bank holding companies.
SUMMARY:
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DATES:
December 18, 2024.
FOR FURTHER INFORMATION CONTACT:
Anna Lee Hewko, Associate Director,
(202) 250–1577, Brian Chernoff,
Manager, (202) 731–8914, Alexander
Jiron, Senior Financial Institution Policy
Analyst II, (202) 450–7350, or Aakash
Jani, Senior Financial Institution Policy
Analyst I, (202) 941–8305, Division of
Supervision and Regulation; or Jay
Schwarz, Deputy Associate General
Counsel, (202) 452–2970, Mark Buresh,
Senior Special Counsel, (202) 499–0261,
Jonah Kind, Senior Counsel, (202) 309–
5287, or David Imhoff, Senior Attorney
(202) 834–3222, Legal Division. Board of
Governors of the Federal Reserve
System, 20th and C NW, Washington,
DC 20551. For the hearing impaired and
users of Telecommunications Device for
the Deaf (TDD) and TTY–TRS, please
call 711 from any telephone, anywhere
in the United States.
SUPPLEMENTARY INFORMATION: The
Board’s framework for determining riskbased capital surcharges for global
systemically important bank holding
companies (GSIB surcharge rule)
establishes a methodology to identify
global systemically important bank
holding companies (GSIBs) in the
United States based on indicators that
are correlated with systemic
importance.1 Under the GSIB surcharge
rule, a firm must calculate its GSIB
score using a specific formula (method
1). Method 1 uses five equally weighted
categories that are correlated with
systemic importance—size,
interconnectedness, cross-jurisdictional
activity, substitutability, and
complexity—and subdivided into
twelve systemic indicators.
A firm divides its own measure of
each systemic indicator by an aggregate
global indicator amount. A firm’s
method 1 score is the sum of its
weighted systemic indicator scores
expressed in basis points. A firm that
calculates a method 1 score of 130 basis
points or more is identified as a GSIB
under the GSIB surcharge rule. The
GSIB surcharge for a firm is the higher
of the GSIB surcharge determined under
method 1 and a second method, method
2, which is calculated based on
measures of size, interconnectedness,
cross-jurisdictional activity, complexity,
and the firm’s reliance on short-term
wholesale funding.2
The aggregate global indicator
amounts used in the score calculation
1 See
12 CFR 217.402, 217.404.
2 uses similar inputs to those used in
method 1 but replaces the substitutability category
with a measure of a firm’s use of short-term
wholesale funding. In addition, method 2 is
calibrated differently from method 1. See 12 CFR
217.405.
2 Method
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]]>Agencies
[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Pages 102903-102908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29829]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0601; FRL-11581-06-OCSPP]
Initiation of Prioritization Under the Toxic Substances Control
Act (TSCA); Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Under the Toxic Substances Control Act (TSCA) and related
implementing regulations, EPA is initiating the prioritization process
for five chemical substances as candidates for designation as High-
Priority Substances for risk evaluation. This action provides the
identity of the chemical substances being initiated for prioritization,
a general explanation of why the Agency chose these chemical
substances, and information on the data sources EPA plans to use to
support the designation. EPA is providing a 90-day comment period,
during which interested persons may submit relevant information on
these chemical substances.
DATES: Comments must be received on or before March 18, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number, through https://www.regulations.gov. Follow the online
instructions for submitting comments. For comments not related to a
specific chemical, including general comments on Unit IV.A., use docket
ID number EPA-HQ-OPPT-2023-0601; submit information on the candidates
for which EPA is initiating the prioritization process to the
applicable chemical-specific docket ID number identified in Unit
III.B.; submit information on the potential candidates for which EPA is
not currently initiating the prioritization
[[Page 102904]]
process to the docket ID number identified in Unit IV.B. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Additional instructions on commenting or visiting the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Sarah Au, Data Gathering, Management,
and Policy Division (7406M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-0398; email address:
[email protected].
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404;
email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action is directed to the public in general and may be of
interest to entities that currently or may manufacture (including
import) a chemical substance regulated under TSCA (e.g., entities
identified under North American Industrial Classification System
(NAICS) codes 325 and 324110). The action may also be of interest to
chemical processors, distributors in commerce, users, non-profit
organizations in the environmental and public health sectors, state and
local government agencies, Tribes, and members of the public. Because
other entities may also be interested, the Agency has not attempted to
describe all the specific entities and corresponding NAICS codes for
entities that may be interested in or affected by this action.
B. What action is the Agency taking?
EPA is initiating the prioritization process under TSCA, 15 U.S.C.
2601 et seq., for five chemical substances as candidates for
designation as High-Priority Substances for risk evaluation. This
document includes the identity of the chemical substances entering the
prioritization process before designation and a general explanation of
why the Agency chose to initiate prioritization on these chemical
substances. In addition, EPA is providing a 90-day comment period
during which interested persons may submit relevant information on
these chemical substances. Relevant information might include, but is
not limited to, any information that may inform the prioritization
screening review conducted pursuant to 40 CFR 702.9(a).
C. Why is the Agency taking this action?
TSCA section 6(b) requires that EPA initiate the prioritization
process for chemical substances that may be designated as high priority
or low priority for risk evaluation. Because EPA generally expects to
complete five risk evaluations per year over the next several years,
EPA is initiating the prioritization process for five chemical
substances per TSCA section 6(b)(3)(C), which requires EPA to designate
at least one High-Priority Substance upon completion of each risk
evaluation for a High-Priority Substance. In the Federal Register on
December 18, 2023 (88 FR 87423) (FRL-11581-01-OCSPP)), EPA initiated
prioritization for five chemical substances that have undergone
consideration as High-Priority Substances pursuant to TSCA section
6(b)(2)(B). By initiating prioritization another five chemical
substances pursuant to TSCA section 6(b)(2)(B), EPA intends to maintain
a sustainable pipeline of existing chemical risk evaluations under TSCA
section 6(b). The request for interested persons to submit relevant
information on a chemical substance for which EPA has initiated the
prioritization process is required by TSCA section 6(b)(1)(C)(i).
D. What is the Agency's authority for taking this action?
This document is issued pursuant to the authority in TSCA section
6(b)(1) and (3)(C).
E. What are the estimated incremental impacts of this action?
This document does not establish requirements on persons or
entities outside of the Agency. No incremental impacts are therefore
anticipated, and consequently EPA did not estimate potential
incremental impacts for this action.
F. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through https://www.regulations.gov or
email. If you wish to include CBI in your comment, please follow the
applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the part or all the information you
claim to be CBI. In addition to one complete version of the comment
including information claimed as CBI, a copy of the comment that does
not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2 and/or 40 CFR part 703, as applicable.
2. Tips for Preparing Your Comments
When preparing and submitting your comments, see the commenting
tips at https://www.epa.gov/dockets/commenting-epa-dockets.html.
II. Background
TSCA section 6(b)(1) requires EPA to prioritize chemical substances
for risk evaluation and to establish a process for prioritizing
chemical substances. Under TSCA section 6(b) and as described in 40 CFR
702.7, EPA is initiating the prioritization process for five chemical
substances as candidates for High-Priority Substances for risk
evaluation.
Under TSCA section 6(b)(1)(B) and its implementing regulations (40
CFR 702.3), a High-Priority Substance is defined as a chemical
substance that EPA determines, without consideration of costs or other
non-risk factors, may present an unreasonable risk of injury to health
or the environment because of a potential hazard and a potential route
of exposure under the conditions of use, including an unreasonable risk
to potentially exposed or susceptible subpopulations identified as
relevant by EPA.
Initiation of prioritization for chemical substances as High-
Priority Substance candidates is not a finding of risk. Rather, when
prioritization is complete, for those chemicals designated as High-
Priority Substances, EPA will have evidence that this substance may
present an unreasonable risk of injury to health or the environment
because of a potential hazard and a potential route of exposure under
the conditions of use. Final designation of a High-Priority Substance
initiates the risk evaluation process (40 CFR 702.17), which culminates
in a finding of whether the chemical substance presents an unreasonable
risk under the conditions of use.
This document is intended to fulfill the TSCA section 6(b)(1)(C)(i)
requirement that the Administrator request interested persons to submit
relevant information on chemical substances for which the Administrator
has initiated the prioritization process. As described in 40 CFR 702.7,
this document initiates the prioritization process and provides 90 days
during which interested persons may submit relevant information.
[[Page 102905]]
As described in 40 CFR 702.9(b), in conducting the screening review
during the prioritization process, EPA will consider sources of
information relevant to the screening review criteria as outlined in
the statute (TSCA section 6(b)(1)(A)) and implementing regulations (40
CFR 702.9(a)) and consistent with the scientific standards of TSCA
section 26(h), including, as appropriate, sources for hazard and
exposure data listed in Appendices A and B of the TSCA Work Plan
Chemicals: Methods Document (February 2012).
Consistent with the approach described in 40 CFR 702.7, and the ``A
Working Approach for Identifying Potential Candidate Chemicals for
Prioritization'' document (September 27, 2018), available at https://www.epa.gov/sites/default/files/2018-09/documents/preprioritization_white_paper_9272018.pdf, EPA consulted with other
federal agencies and intends to continue to collaborate with them to
identify information that is useful throughout the prioritization
process.
III. High Priority Candidate Chemical Substances for Which EPA Is
Initiating Prioritization
A. How did EPA select these candidates for prioritization for potential
designation as High-Priority Substances for risk evaluation?
In general, EPA's working approach to select candidates for
designation as High-Priority Substances for risk evaluation is outlined
in the document, titled ``A Working Approach for Identifying Potential
Candidate Chemicals for Prioritization,'' released to the public on
September 27, 2018, available at https://www.epa.gov/sites/default/files/2018-09/documents/preprioritization_white_paper_9272018.pdf. To
identify candidates for designation as High-Priority Substances, EPA
primarily reviewed the ``TSCA Work Plan for Chemical Assessments: 2014
Update (2014 TSCA Work Plan),'' available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-assessments-2014-update. TSCA requires EPA to preferentially consider
chemicals on the 2014 TSCA Work Plan that are persistent and
bioaccumulative and those that are known human carcinogens and highly
toxic, based on scores and criteria documented in the Work Plan, as
these chemicals were selected for inclusion on the Work Plan due to
their potential risk to human health and the environment. Aside from
this statutory requirement, TSCA gives EPA discretion in how the Agency
ultimately selects a chemical substance for prioritization. EPA strives
to designate as High-Priority Substances those chemicals with the
greatest hazard and exposure potential first, consistent with the
policy objectives codified in 40 CFR 702.5(a) in the Federal Register
on July 20, 2017 (82 FR 33753) (FRL-9964-24)).
The number of chemical substances remaining on the 2014 TSCA Work
Plan with persistence and bioaccumulation scores of 3 has been
significantly reduced over time as EPA has expedited rulemaking under
TSCA section 6(h) for five persistent, bioaccumulative, and toxic (PBT)
chemical substances and as the Agency has conducted risk evaluations
and promulgated risk management for rules for other chemical substances
from the 2014 TSCA Work Plan. TSCA section 6(b)(2)(B) further requires
that at least 50 percent of all ongoing risk evaluations be drawn from
the 2014 TSCA Work Plan for Chemical Assessments. Given EPA's statutory
deadlines and the timing of prioritization actions needed to offset the
completion of risk evaluations for chemical substances designated as
High-Priority Substances in 2019, EPA heavily weighed data availability
in deciding which chemical substances to include in this action.
Chemical substances remaining on the 2014 TSCA Work Plan that have
persistence and bioaccumulation scores of 3 have significant data gaps,
were submitted as potential manufacturer-requested risk evaluation
candidates or are categories for which EPA is in the process of
determining specific chemical structures that may be considered for
inclusion in those categories.
EPA consulted with other EPA program offices and partner federal
agencies to inform the Agency's prioritization efforts. With these
considerations, the chemicals for which prioritization is initiated in
this action were selected based on a variety of factors and reflect
Agency priorities. While data availability was a significant driver of
the Agency's selections, EPA also considered the complexity of
evaluating broad chemical categories such as metal compounds. For EPA
to build a sustainable TSCA prioritization, evaluation, and (when
appropriate) risk management pipeline, chemicals ultimately designated
as High-Priority Substances for risk evaluation should have a robust
data landscape. In future rounds of prioritization, EPA intends to use
its data gathering authorities earlier and commits to regular
stakeholder engagement to ensure the Agency has the information needed
to meet its statutory mandates.
Using data sources such as those described in the document titled,
``A Working Approach for Identifying Potential Candidate Chemicals for
Prioritization,'' EPA considered various types of information and data
from existing resources such as EPA's National Center for Computational
Toxicology's Chemistry Dashboard (CompTox Chemicals Dashboard),
available at https://comptox.epa.gov/dashboard. EPA also conducted
initial searches of additional sources of public and gray literature
(e.g., PubMed, Web of Science, other U.S. government and international
websites).
EPA also considered existing information from public and non-public
(i.e., confidential business information) sources maintained by
authoritative sources, such as other EPA program offices, state and
federal agencies, and various U.S. and international organizations
(including but not limited to EPA's Office of Water, EPA's Office of
Air and Radiation, EPA's Office of Research and Development, California
Environmental Protection Agency, National Institute for Occupational
Safety and Health, Agency for Toxic Substances and Disease Registry,
European Chemicals Agency, Health Canada, International Agency for
Research on Cancer, and Organisation for Economic Co-operation and
Development).
After identifying information from reasonably available sources,
the information was screened across several data elements including
physical and chemical properties, environmental fate and transport
properties, hazard, exposure, and use information to determine the
breadth of data availability for a chemical substance. Using experience
gained from TSCA implementation activities to date, EPA considered
previous and planned Agency activities related to a given chemical
substance, including how to better leverage experience gained from
previously conducted or ongoing risk evaluations. EPA also considered
whether analyses from previous risk assessments could be used to better
understand each chemical substance's potential exposure and/or hazard
characteristics.
In the absence of measured empirical data on chemicals being
evaluated, EPA may use alternative means or new approach methods (NAMs)
to obtain relevant data. NAMs can reduce vertebrate testing, consistent
with TSCA section 4(h)(1)(A). EPA intends to use this approach to the
extent practicable and scientifically justified.
EPA also considered information such as data submitted to EPA in
2020 under
[[Page 102906]]
the Chemical Data Reporting (CDR) rule under TSCA regarding reported
uses and products to inform prioritization and risk evaluation. EPA
considered the use information for these chemicals and screened them
according to the types of industrial uses and types of products for
which the chemicals were used as reported in the 2020 CDR. Information
reported to the Toxics Release Inventory Program was also considered to
identify reported uses and releases of chemical substances.
EPA intends to update and refine its initial review based on data
sources identified by the public during the comment period (see EPA's
request for data in Unit IV.) and, as permitted by TSCA section 14 and
subject to EPA confidentiality regulations at 40 CFR part 2, subpart B
and 40 CFR part 703, intends to make this information publicly
available for the initiated chemicals when EPA publishes the proposed
priority designation.
Between December 18, 2023, and October 31, 2024, EPA received
information regarding candidate chemical substances being considered
for prioritization actions during two periods. During September and
October 2023, EPA hosted a series of pre-prioritization meetings with
various stakeholders, Tribes, state and local governments, and other
federal agencies to explain the prioritization process and provide an
overview of information that may be used to inform the considerations
that ultimately support a High- or Low-Priority Substance designation.
A list of 15 candidate chemical substances being considered for future
prioritization actions, including those undergoing initiation in this
prioritization action, was presented to provide an opportunity for
partners, stakeholders, and any interested persons to comment on the
data and scientific literature available that may be used to help EPA
determine which chemical substances may undergo prioritization in the
near term. EPA also opened docket ID No. EPA-HQ-OPPT-2023-0606 for 90
days to receive any potentially relevant information on the 10 chemical
substances communicated as candidates for prioritization but not
selected for initiation on December 18, 2023, which included the
chemical substances for which prioritization is being initiated with
this action.
As a part of EPA's commitment to greater transparency and to
maintain engagement with partners, stakeholders or any interested
persons about upcoming prioritization actions, EPA hosted public
webinars on September 30 and October 1, 2024, that explained the
prioritization process, provided an overview of information that may be
used to inform the considerations that ultimately support a High- or
Low-Priority Substance designation, and shared an expanded list of 27
candidate chemical substances being considered for prioritization
actions. This expanded list included the 10 chemical substances
previously communicated in 2023 as being potential candidates for
prioritization but not yet selected for initiation. Following the
public webinars, EPA opened docket ID No. EPA-HQ-OPPT-2023-0606 for 30
days to receive any potentially relevant information on the 27 chemical
substances communicated as being candidates for prioritization. EPA
also engaged with Tribes, state and local governments, and other
federal agencies and presented the same information that was provided
during the public webinars.
EPA considered all comments and information received during the
various meetings and webinars, as well as those submitted to docket ID
no. EPA-HQ-OPPT-2023-0606 on all candidate chemical substances
considered for prioritization actions communicated between September
2023 and October 2024 to identify the five chemical substances being
initiated for prioritization. During the first 90-day public comment
period accompanying the initiation action that began in December 2023,
EPA received comments pertaining to six chemical substances
communicated as potential candidates for prioritization during the pre-
prioritization presentations in September and October 2023 and
September and October 2024: 4-tert- octylphenol, N-(1,3-Dimethylbutyl)-
N'-phenyl-p-phenylenediamine (6PPD), benzene, ethylbenzene,
naphthalene, and styrene.
One commentor (EPA-HQ-OPPT-2018-0448-0027) wrote in general support
of the consideration of benzene, ethylbenzene, naphthalene, and styrene
for upcoming prioritization actions and the consideration of submitted
information on natural disasters and environmental impacts on potential
exposure.
Some commenters (EPA-HQ-OPPT-2023-0606-0005; EPA-HQ-OPPT-2023-0606-
0006; EPA-HQ-OPPT-2023-0606-0007) included information on 6PPD and/or
6PPD-quinone (a degradation product of 6PPD) for consideration in
upcoming prioritization actions and in support of the petition
submitted under TSCA section 21 requesting the promulgation of risk
management regulations under TSCA section 6(a) to prohibit the
manufacturing, processing, use and distribution of 6PPD for and in
tires to eliminate unreasonable risk to the environment.
Another commenter (EPA-HQ-OPPT-2023-0606-0005) requested that
docket ID. No. EPA-HQ-OPPT-2023-0606 remain open to allow for
continuous submission of potentially relevant information regarding the
characterization of 6PPD risk. EPA intends to re-open docket ID No.
EPA-HQ-OPPT-2023-0606 during specific timeframes during pre-
prioritization to allow for submission of information using
regulations.gov.
As described in Unit IV.B., EPA is also re-opening docket ID No.
EPA-HQ-OPPT-2023-0606 to solicit comments and information on 22
chemical substances that are candidates for future prioritization
actions. Regarding the TSCA section 21 petition from Earthjustice on
behalf of the Yurok Tribe, the Port Gamble S'Klallam Tribe, and the
Puyallup Tribe of Indians, EPA issued an Advance Notice of Proposed
Rulemaking in the Federal Register on November 18, 2024 (89 FR 91299)
(FRL-11682-01-OCSPP)) for 6PPD and 6PPD-quinone under TSCA section
6(a), and is committed to finalizing a TSCA section 8(d) rulemaking by
the end of 2024 that would require persons who manufacture (including
import) 6PPD to submit lists or copies of unpublished health and safety
studies to EPA.
One commentor (EPA-HQ-OPPT-2023-0606-0003) stated that the
information presented in the 2014 TSCA Work Plan was incorrect for 4-
tert-octylphenol and that EPA should not include 4-tert-octylphenol on
the fourth Candidate Chemical List under SDWA. Under TSCA, EPA is
required to consider chemical substances identified in the 2014 TSCA
Work Plan and does not plan to revise the Work Plan as part of this
action. Additional information received regarding the potential hazard,
potential exposure, and bioaccumulation and persistence of 4-tert-
octylphenol may be considered during prioritization.
For more information on the comments and EPA's responses regarding
the candidate chemical substances, see Section 1.7 and 7.1 of the ``EPA
Response to Public Comments Received on the ``Initiation of
Prioritization Under the Toxic Substances Control Act'' and ``Proposed
High-Priority Substance Designations Under the Toxic Substances Control
Act'' document published in docket ID no. EPA-HQ-OPPT-2023-0601 and
EPA-HQ-OPPT-2023-0606.
[[Page 102907]]
B. What chemicals are being initiated?
EPA is initiating the prioritization process for the following five
chemicals as candidates for designation as High-Priority Substances:
1. 4-Tert-Octylphenol, CASRN 140-66-9, Docket ID No.: EPA-HQ-OPPT-2018-
0496
This chemical was listed in the 2014 TSCA Work Plan with a hazard
score of 3; an exposure score of 3; and a persistence and
bioaccumulation score of 2. Exposure to 4-tert-octyphenol (4-(1,1,3,3-
tetramethylbutyl)-phenol may result in a range of human health effects
such as kidney inflammation and impaired fertility (i.e., lowered sperm
count). Data related to human carcinogenicity have not been identified.
Data regarding the use of this chemical was reported to EPA in the 2020
CDR. EPA also receives information annually on this chemical through
the Toxics Release Inventory (TRI). Information is available from
assessments conducted by international organizations, and other
countries.
2. Benzene, CASRN 71-43-2, Docket ID No.: EPA-HQ-OPPT-2018-0475
This chemical was listed in the 2014 TSCA Work Plan with a hazard
score of 3; an exposure score of 3; and a persistence and
bioaccumulation score of 1. Data regarding the use of this chemical was
reported to EPA in the 2020 CDR. Benzene is a known human carcinogen.
Exposure to benzene may also result in a range of health effects such
as immune function (e.g., decreased immune lymphocyte count) and
developmental abnormalities (i.e., fetal malformations). EPA also
receives information annually on this chemical through the TRI.
Information is available from assessments conducted by other federal
agencies, the state of California, international organizations, and
other countries.
3. Ethylbenzene, CAS RN 100-41-4, Docket ID No.: EPA-HQ-OPPT-2018-0487
This chemical was listed in the 2014 TSCA Work Plan with a hazard
score of 3; an exposure score of 3; and a persistence and
bioaccumulation score of 1. Ethylbenzene is a probable human
carcinogen. Exposure to ethylbenzene may also result in a range of
health effects such as changes to liver and kidney tissue, hearing
loss, and developmental abnormalities (i.e., fetal malformations). Data
regarding the use of this chemical was reported to EPA in the 2020 CDR.
EPA also receives information annually on this chemical through the
TRI. Information is available from assessments conducted by other
federal agencies, the state of California, international organizations,
and other countries.
4. Naphthalene, CASRN 91-20-3, Docket ID No.: EPA-HQ-OPPT-2018-0454
This chemical was listed in the 2014 TSCA Work Plan with a hazard
score of 3; an exposure score of 3; and a persistence and
bioaccumulation score of 2. Naphthalene is a probable human carcinogen.
Exposure to naphthalene may also result in a range of health effects
such as destruction of red blood cells resulting in lower blood oxygen,
damage to eyesight, and changes to liver, lung, and nasal tissue. Data
regarding the use of this chemical was reported to EPA in the 2020 CDR.
EPA also receives information annually on this chemical through the
TRI. Information is available from assessments conducted by other
federal agencies, the state of California, international organizations,
and other countries.
5. Styrene, CASRN 100-42-5, Docket ID No.: EPA-HQ-OPPT-2018-0461
This chemical was listed in the 2014 TSCA Work Plan with a hazard
score of 3; an exposure score of 3; and a persistence and
bioaccumulation score of 1. Styrene is a probable human carcinogen.
Exposure to styrene may also result in a range of health effects such
as hearing loss, memory loss, fetal death, and tissue changes in the
lungs and nasal passages. Data regarding the use of this chemical was
reported to EPA in the 2020 CDR. EPA also receives information annually
on this chemical through the TRI. Information is available from
assessments conducted by other federal agencies, the state of
California, international organizations, and other countries.
IV. Relevant Information
A. What additional information is EPA seeking for the five candidate
chemical substances for which EPA is initiating prioritization?
Through this initiation of prioritization for chemical substances,
EPA is providing a 90-day comment period as required by the statute
(TSCA section 6(b)(1)(C)(i)) and implementing regulations (40 CFR
702.7(d)) and requesting that interested persons voluntarily submit
relevant information. Relevant information might include, but is not
limited to, information that may inform the screening review conducted
pursuant to 40 CFR 702.9(a), consistent with the scientific standard of
TSCA section 26(h), about the following criteria and considerations:
The chemical substance's hazard and exposure potential;
The chemical substance's persistence and bioaccumulation;
Potentially exposed or susceptible subpopulations which
the submitter believes are relevant to the prioritization;
Whether there is any storage of the chemical substance
near significant sources of drinking water, including the storage
facility location and the nearby drinking water source(s);
The chemical substance's conditions of use or significant
changes in conditions of use, including information regarding trade
names;
The chemical substance's production volume or significant
changes in production volume; and
Any other information relevant to the potential risks of
the chemical substance that might be relevant to the designation of the
chemical substance's priority for risk evaluation.
If the information is publicly available, citations are sufficient
(including, but not limited to: Title, author, date of publication,
publication source), and the submission does not need to include copies
of the information.
B. What information is the Agency seeking for the 22 additional
chemical substances that EPA considered, but did not select, for the
current round of prioritization?
During the pre-prioritization process, EPA hosted public webinars
and met with federal partners, industry, environmental organizations,
labor organizations, state and local governments, and Tribes to discuss
the prioritization process and presented a list of 27 chemical
substances EPA was considering for prioritization. EPA took feedback
from these discussions into consideration when selecting the five
chemicals for prioritization listed in Unit III.B. Interested persons
may submit relevant information on the chemical substances listed in
this unit that are not currently undergoing prioritization by using
docket ID number EPA-HQ-OPPT-2023-0606.
EPA has not yet determined which specific chemical structures are
being considered for the chemical substances designated as a category
in the 2014 TSCA Work Plan (i.e., do not have CASRN listed). Therefore,
EPA welcomes comments and information on specific chemical structures
that may be relevant for addressing the various prioritization criteria
and considerations on the chemical categories listed in this
[[Page 102908]]
unit. Information submitted on the substances within a category should
be reported for each individual chemical structure, to the extent
possible (i.e., known or reasonably ascertainable). If the chemical
identity of some of the individual chemical structures are not known or
reasonably ascertainable by the commenter, the information associated
with those chemical substances may be reported as a group of chemical
structures (i.e., isomeric mixture) or as the chemical category:
1-Hexadecanol, CASRN 36653-82-4;
2-Ethylhexyl 2,3,4,5-tetrabromobenzoate (TBB), CASRN
183658-27-7;
Bis(2-Ethylhexyl)-3,4,5,6-Tetrabromophthalate (TBPH),
CASRN 26040-51-7;
Bisphenol A, CASRN 80-05-7;
Creosote, CASRN 8001-58-9;
Di-n-octyl phthalate (DnOP), CASRN 117-84-0;
N-Nitroso-diphenylamine, CASRN 86-30-6;
P,P'-Oxybis(benzenesulfonylhydrazide), CASRN 80-51-3;
Tribromomethane, CASRN 75-25-2;
Triglycidyl isocyanurate, CASRN 2451-62-9;
M-Xylene, CASRN 108-38-3;
O-Xylene, CASRN 95-47-6;
P-Xylene, CASRN 106-42-3;
Antimony and Antimony Compounds, Category;
Arsenic and Arsenic Compounds, Category;
Cobalt and Cobalt Compounds, Category;
Lead and Lead Compounds, Category;
Long-chain chlorinated paraffins (C18-20), Category;
Medium-chain chlorinated paraffins (C14-17), Category;
Bisphenol S, CASRN 80-09-1;
Hydrogen Fluoride, CASRN 7664-39-3;
N-(1,3-Dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD),
CASRN 793-24-8.
C. How will confidential business information be protected?
A person seeking to protect from disclosure as ``confidential
business information'' any information that person submits under TSCA
must assert and substantiate a claim for protection from disclosure
concurrent with submission of the information in accordance with the
requirements of TSCA section 14 and 40 CFR 703, with limited exceptions
provided in the statute. TSCA section 14(b) limits confidentiality
protections for health and safety studies and information from such
studies, however, and while EPA considers confidential business
information when conducting its review under 40 CFR 702.9(a), the
Agency encourages submitters to minimize claims for protection from
disclosure wherever possible to maximize transparency in EPA's
screening review. More information on asserting and submitting
confidential business information claims under TSCA can be found at 40
CFR 703 and https://www.epa.gov/tsca-cbi.
Authority: 15 U.S.C. 2601 et seq.
Dated: December 12, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-29829 Filed 12-17-24; 8:45 am]
BILLING CODE 6560-50-P
