[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Pages 102900-102903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29830]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0601; FRL-11581-07-OCSPP]
High-Priority Substance Designations Under the Toxic Substances
Control Act (TSCA) and Initiation of Risk Evaluation on High-Priority
Substances; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: Under the Toxic Substances Control Act (TSCA) and related
implementing regulations, EPA is designating five chemicals as High-
Priority Substances for risk evaluation. This document provides the
identity of five chemical substances for final designation as High-
Priority Substances for risk evaluation, EPA's rationale for final
designation as High-Priority Substances, and instructions on how to
access the chemical-specific information, analysis, and basis EPA used
to support final designations for the chemical substances. A
designation of a substance as a High-Priority Substance is not a
finding of unreasonable risk. Rather, the designation of these chemical
substances as high priority constitutes the initiation of evaluation of
associated risk.
DATES: The designations of High-Priority Substances for risk evaluation
in this notice are effective December 18, 2024.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2023-0601, is available online
at https://www.regulations.gov. In addition, the docket ID numbers for
the individual chemical substances designated in Unit IV. are as
follows: Acetaldehyde (EPA-HQ-OPPT-2018-0497); Acrylonitrile (EPA-HQ-
OPPT-2018-0449); Benzenamine (EPA-HQ-OPPT-2018-0474); Vinyl Chloride
(EPA-HQ-OPPT-2018-0448); and 4,4'-Methylene bis (2- chloroaniline)
(MBOCA) (EPA-HQ-OPPT-2018-0464). Additional information about dockets
generally, along with instructions for visiting the docket in-person,
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, and users, non-
governmental organizations in the environmental and public health
sectors, state and local government agencies, Tribes, and members of
the public. Since other entities may also be interested, EPA 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 finalizing the designation of five chemical substances as
High-Priority Substances for risk evaluation pursuant to section 6(b)
of TSCA, 15 U.S.C. 2605(b). This document includes a high-level summary
of comments received during the two 90-day comment periods during which
the public submitted comments on EPA's initiation of prioritization
(Ref. 1) and the proposed designations of those five chemicals as High-
Priority Substances for risk evaluation (Ref. 2), as well as a high-
level summary of Agency responses to those comments received during
both 90-day public comment periods. The comments and EPA's responses
are discussed in more depth in the response to comments document (Ref.
3). EPA also considered comments received during and following the
prioritization public webinar that occurred in February 2024, during
which EPA explained the prioritization process and provided an overview
of information that may be used to inform the considerations that
ultimately support a High- or Low-Priority Substance designation, such
as information on conditions of use and health effects resulting from
exposure to the chemicals of interest.
C. Why is the Agency taking this action?
TSCA section 6(b) and implementing regulations at 40 CFR part 702,
subpart A require EPA to carry out a prioritization process for
chemical substances that may be designated as high priority for risk
evaluation. EPA generally expects to complete five risk evaluations per
year over the next several years, and TSCA section 6(b)(3)(C) requires
EPA to designate at least one High-Priority Substance upon completion
of each risk evaluation for a High-Priority Substance. Pursuant to TSCA
section 6(b)(2)(B), EPA is finalizing the designation of the five
chemical substances as High-Priority Substances for risk evaluation
identified as candidates for High-Priority Substance designation when
EPA initiated the prioritization process on December 18, 2023 (Ref. 1).
As required under TSCA section 6(b)(3)(C), EPA is specifying the
designation of: MBOCA to replace the final risk evaluation for 1,1-
dichloroethane; acetaldehyde to replace the final risk evaluation for
1,3-butadiene; acrylonitrile to replace the final risk evaluation for
dicyclohexyl phthalate; benzenamine to replace the final risk
evaluation for formaldehyde; and vinyl chloride to replace the final
risk evaluation for tris(2-chloroethyl) phosphate.
D. What is the Agency's authority for taking this action?
This document is issued pursuant to TSCA section 6(b)(1) and
6(b)(3)(C).
E. What are the estimated incremental impacts of this action?
This document identifies the five chemical substances for which EPA
is initiating the risk evaluation process and the five chemical
substances that have already or will have risk evaluations completed
which they will replace. This document does not establish any
requirements on persons or entities outside of the Agency. No
incremental impacts are therefore anticipated, and consequently EPA did
[[Page 102901]]
not estimate potential incremental impacts for this action.
II. Background
TSCA section 6(b)(1) requires EPA to prioritize chemical substances
for risk evaluation. In accordance with TSCA section 6(b) and 40 CFR
702.7, on December 18, 2023 (Ref. 1) EPA initiated the prioritization
process for five chemical substances identified as candidates for High-
Priority Substance designation. On July 25, 2024, EPA proposed to
designate the same five chemical substances as High-Priority Substances
for risk evaluation (Ref. 2). That notice included a summary of the
approach used by EPA to support the proposed designations, links to the
proposed designation document for each of the chemical substances, and
instructions on how to access the chemical-specific information,
analysis, and basis EPA used to make the proposed designation for each
chemical substance.
Under TSCA section 6(b)(1)(B) and implementing regulations (40 CFR
702.3), a High-Priority Substance is defined as ``a chemical substance
that EPA concludes, 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
a potentially exposed or susceptible subpopulation identified as
relevant by EPA.''
A designation of a substance as a High-Priority Substance is not a
finding of unreasonable risk. Rather, when prioritization is complete,
for those chemicals designated as High-Priority Substances, the Agency
will have evidence on hazards and exposures that supports a finding
that the substances may present an unreasonable risk of injury to
health or the environment 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 of injury to health or
the environment under the conditions of use.
As described in the notice proposing to designate the five chemical
substances as High-Priority Substances for risk evaluation (Ref. 2),
``EPA will generally use reasonably available information to screen the
candidate chemical substance[s] against 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;
Storage of the chemical substance near significant sources
of drinking water;
The chemical substance's conditions of use or significant
changes in conditions of use;
The chemical substance's production volume or significant
changes in production volume; and
Other risk-based criteria that EPA determines to be
relevant to the designation of the chemical substance's priority'' (40
CFR 702.9(a)).
When selecting candidates for prioritization, the Agency also
generally intends to consider (1) Agency priorities (with consideration
of the priorities of other Federal agencies), (2) Quantity and quality
of information (to ensure that information necessary to prioritize the
substance is reasonably available), and (3) Overall workload (the
Agency will be mindful of the complexity associated with the assessment
of the chemical substance to ensure timely completion of prioritization
and risk evaluation of each substance) (Ref. 5).
A more detailed discussion of the information, analysis, and basis
used to support the proposed High-Priority Substance designation can be
found in Unit IV.A of the July 25, 2024, notice (Ref. 2).
As described in 40 CFR 702.9(b), in conducting the screening review
during the prioritization process, EPA considered sources of reasonably
available information relevant to the 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), and did not consider
costs or other non-risk factors in making a proposed High-Priority
Substance designation (see TSCA Section 6(b) and 40 CFR 702.9).
After considering additional information collected from the
proposed designation process, described in Unit III., EPA is finalizing
the High-Priority Substance designations of the same five chemical
substances proposed for High-Priority Substance designations,
consistent with the scientific standards of TSCA section 26(h) and (i).
EPA did not consider costs or other non-risk factors in making the
final priority designations. Instructions on how to access the
chemical-specific information, analysis, and basis used by EPA to
support the final designation for each chemical substance can be found
in Unit IV. A general statement of the condition(s) of use that were
the primary basis for each designation is contained in Unit IV.
Pursuant to TSCA section 6(b)(3)(A) and 40 CFR 702.17, the designation
of these chemical substances as High-Priority Substances constitutes
the initiation of the risk evaluations on the substances.
III. Information and Comments Received
A. Overview of Public Comments
EPA provided a 90-day comment period for the public to submit
comments on the list of candidate High-Priority Substances immediately
following the initiation of prioritization (Ref. 1) and provided a
second 90-day comment period for the public to submit comments on the
documents supporting the proposed designations of High-Priority
Substances for risk evaluation (Ref. 2). The two comment periods are
required by TSCA section 6(b)(1)(C) and implementing regulations (40
CFR 702.7(d) and 702.9(g)).
Under TSCA section 6(b)(1)(C)(i), EPA must ``request interested
persons to submit relevant information on a chemical substance that EPA
has initiated the prioritization process on, before proposing a
priority designation for the chemical substance, and provide 90 days
for such information to be provided'' (Ref. 1). At initiation of the
prioritization process, EPA published a Federal Register notice
identifying five chemical substances and provided a general explanation
for why the Agency chose to initiate prioritization on those chemical
substances. During this comment period, the public was invited to
submit relevant information on the chemical substances undergoing
prioritization, including, but not limited to, any information that may
inform the screening review conducted pursuant to 40 CFR 702.9(a). The
information received was considered when developing the proposed
designations for the High-Priority Substances. The required 90-day
comment period was extended for an additional 30 days to receive
chemical-specific comments and information for MBOCA (docket ID No.
EPA-HQ-OPPT-2018-0464). The second 90-day comment period following the
proposed High-Priority Substance designations of the same five chemical
substances identified as candidates for High-Priority Substance
designation. Under TSCA section 6(b)(1)(C)(ii), EPA must ``publish each
proposed designation of a chemical
[[Page 102902]]
substance as a High- or Low-Priority Substance, along with an
identification of the information, analysis, and basis used to make the
proposed designations, and provide 90 days for public comment on each
such proposed designation'' (Ref. 2). The Federal Register notice
proposing the designations of these substances as High-Priority for
risk evaluation identified how to access the chemical-specific
information, analysis, and basis used to support the proposed
designations and announced the availability of a proposed designation
document for each of the chemical substances undergoing prioritization.
Interested persons were invited to submit comments, including
additional information relevant to the chemical substances that were
proposed as high priority for risk evaluations.
To the extent that comments from the first comment period provided
information on additional conditions of use for the candidate High-
Priority Substances, those conditions of use were discussed in the
proposed designation documents for each chemical substance. Other
information received specific to High-Priority Substances (e.g.,
relevant studies and assessments) was considered when making the final
priority designations and will be considered as reasonably available
information in the subsequent risk evaluation for each High-Priority
Substance.
Following a public webinar on February 20, 2024, EPA also received
comments on the prioritization process and data considered up until
that date for the five chemical substances for which EPA initiated
prioritization in December 2023. The comments received were considered
when developing the proposed and final designations for the High-
Priority Substances.
EPA created one general docket to receive comments regarding the
prioritization process (docket ID No. EPA-HQ-OPPT-2023-0601) and
additional dockets to receive chemical-specific information (as
identified under ADDRESSES). During the first public comment period,
EPA also opened the pre-prioritization docket (docket ID No. EPA-HQ-
OPPT-2023-0606) to welcome potentially relevant information and
comments on the candidate chemical substances that were not selected
for prioritization.
EPA received 96,011 comment submissions to inform prioritization;
several of these comments were mass mailing campaigns with identical
submissions. There were also many comments that could not be posted
publicly due to inappropriate language, copyright violations, and empty
submissions. Upon review, EPA received 977 unique submissions across
both public comment periods. Some commenters included comments for
multiple chemical substances in one submission and submitted the same
comment to multiple dockets while other commenters chose to submit
different sets of comments to each chemical-specific docket. EPA
received submissions from individuals, Tribes, potentially affected
businesses or trade associations, environmental and public health
advocacy groups, academia, and other organizations. Comments addressed
the overall prioritization process (e.g., the collection and
consideration of relevant information, basis for designation, etc.),
the review process (e.g., the use of data and approaches for screening
review), information specific to the candidate chemical substances
(e.g., relevant studies, previous assessments, and conditions of use
information), as well as topics beyond the scope of this prioritization
action or not related to the prioritization process in general (e.g.,
scheduling future chemicals for prioritization, risk evaluation, and
risk management). EPA also received a few comments which were not
related to TSCA. All comments received are identified by their
respective docket ID number and are available at https://www.regulations.gov.
EPA responded to comments related to the High-Priority Substance
designations in two general categories: (1) General comments, including
overarching and cross-cutting policy and process comments, received for
the candidate High-Priority Substance designations; and (2) Chemical-
specific comments received on each proposed High-Priority Substance
designation (Ref. 3). A high-level summary of the comments received
related to the prioritization process and Agency responses follows in
this unit. The comments and the Agency's responses are discussed in
more depth in the response to comments document (Ref. 3), a copy of
which is included in docket ID No. EPA-HQ-OPPT-2023-0601.
B. Comments on Candidate High-Priority Designations
EPA received 748 unique comments during the first public comment
period between December 18, 2023, and March 18, 2024, and 229 unique
comments during the second comment period from July 25, 2024, to
October 23, 2024, resulting in a total of 977 unique comment
submissions. An additional two comment submissions were received for
MBOCA during the 30-day extension of the first public comment period
for Docket ID number: EPA-HQ-OPPT-2018-0464.
EPA received several mass-mailing campaigns, totaling over 13,000
signatures. All mass-mailing campaigns expressed their support for the
prioritization process and encouraged EPA to prioritize one or all of
the chemicals. Specifically, many of the mass mailing campaigns
encouraged EPA to designate vinyl chloride as a High-Priority Substance
under TSCA. In addition to the mass-mailing campaigns and 17 commenters
who attended the prioritization public webinars in February 2024, EPA
received over 100 comments expressing support for EPA's prioritization
actions.
Commenters expressed their concern regarding human health hazards
and exposure potential of all five of the High-Priority Substances and
asked that EPA consider specific potential health outcomes and exposure
scenarios. Several commenters urged EPA to identify relevant
potentially exposed or susceptible subpopulations (PESS), including
infants, children, pregnant women, workers, the elderly, and people
living in proximity to sources of contamination, as well as consider
environmental justice concerns in the prioritization process. In
addition, several commenters, including some of the mass-mailing
campaigns, urged the Agency to consider all potential exposures and
risks, including those from accidents, spills, and leaks, specifically
potential exposure resulting from transportation incidents such as
derailments and collisions, which may pose significant risk to fence
line communities.
Over 600 commenters asked EPA to ban vinyl chloride and emphasized
the availability of hazard and exposure data demonstrating harm posed
by vinyl chloride releases. Many commenters also cited the February 3,
2023, train derailment that resulted in the release of and potential
exposure to vinyl chloride by residents in East Palestine, Ohio.
Each data submission and potentially relevant data source was
screened using systematic review approaches for applicability and
considered for the final designation of these chemical substances as
High-Priority Substances and will be considered as reasonably available
information.
The Agency appreciates all comments and information submitted by
the public for this action. For additional information regarding
specific topics and EPA's responses to these comments, please see the
Agency's full response to comments received (Ref. 3).
[[Page 102903]]
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 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 High-
Priority 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 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]
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