Dicyclohexyl phthalate (DCHP); Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability and Request for Comment, 1125-1127 [2025-00137]
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The application will be processed
according to the following schedule.
Revisions to the schedule may be made
as appropriate.
Milestone
Commission issues EA ......
Target date
December 31, 2025.
Any questions regarding this notice
may be directed to Kristine Sillett at
(202) 502–6575 or kristine.sillett@
ferc.gov.
Dated: December 31, 2024.
Debbie-Anne A. Reese,
Secretary.
others, access publicly available
information and navigate Commission
processes. For public inquiries and
assistance with making filings such as
interventions, comments, or requests for
rehearing, the public is encouraged to
contact OPP at (202) 502–6595 or OPP@
ferc.gov.
The application will be processed
according to the following schedule.
Revisions to the schedule may be made
as appropriate.
Milestone
Commission issues EA ......
[FR Doc. 2025–00088 Filed 1–6–25; 8:45 am]
Target date
December 31, 2025.
Any questions regarding this notice
may be directed to Kristine Sillett at
(202) 502–6575 or kristine.sillett@
ferc.gov.
BILLING CODE 6717–01–P
DEPARTMENT OF ENERGY
Federal Energy Regulatory
Commission
Dated: December 31, 2024.
Debbie-Anne A. Reese,
Secretary.
[Project No. 2509–051]
[FR Doc. 2025–00086 Filed 1–6–25; 8:45 am]
BILLING CODE 6717–01–P
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PE Hydro Generation, LLC; Notice of
Intent To Prepare an Environmental
Assessment
On January 3, 2022, the PE Hydro
Generation, LLC filed a subsequent
minor license application for the 862kilowatt Shenandoah Hydroelectric
Project No. 2509 (project). The project is
located on the South Fork of the
Shenandoah River near the Town of
Shenandoah in Page and Rockingham,
Counties, Virginia.
In accordance with the Commission’s
regulations, on October 18, 2024,
Commission staff issued a notice that
the project was ready for environmental
analysis (REA Notice). Based on the
information in the record, staff does not
anticipate that licensing the project
would constitute a major Federal action
significantly affecting the quality of the
human environment. Therefore, staff
intends to prepare an Environmental
Assessment (EA) on the application to
license the project.1
The EA will be issued and circulated
for review by all interested parties. All
comments filed on the EA will be
analyzed by staff and considered in the
Commission’s final licensing decision.
The Commission’s Office of Public
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members of the public, including
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communities, Tribal members, and
1 In accordance with the Council on
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identification number for documents relating to this
environmental review is EAXX–019–20–000–
1734604304. 40 CFR 1501.5(c)(4) (2024).
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ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2018–0504; FRL–12481–
01–OCSPP]
Dicyclohexyl phthalate (DCHP); Draft
Risk Evaluation Under the Toxic
Substances Control Act (TSCA); Notice
of Availability and Request for
Comment
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Environmental Protection
Agency (EPA or Agency) is announcing
the availability of and seeking public
comment on a draft risk evaluation
under the Toxic Substances Control Act
(TSCA) for Dicyclohexyl phthalate
(DCHP) (1,2-benzenedicarboxylic acid,
1,2-dicyclohexyl ester) (CASRN 84–61–
7). The purpose of risk evaluations
under TSCA is to determine whether a
chemical substance presents an
unreasonable risk of injury to health or
the environment, without consideration
of costs or other non-risk factors,
including unreasonable risk to
potentially exposed or susceptible
subpopulations identified as relevant to
the risk evaluation by EPA, under the
conditions of use. EPA has used the best
available science to prepare this draft
risk evaluation and to preliminarily
determine that DCHP poses
unreasonable risk to human health.
DATES: Comments must be received on
or before March 10, 2025.
SUMMARY:
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1125
Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2018–0504,
online at https://www.regulations.gov.
Follow the online instructions for
submitting comments. 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
and visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
FOR FURTHER INFORMATION CONTACT:
Chemical specific information: Claire
Brisse, Existing Chemical Risk
Management Division (7404M), Office of
Pollution Prevention and Toxics,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
564–9004; email address: brisse.claire@
epa.gov.
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:
ADDRESSES:
I. Executive Summary
A. Does this action apply to me?
This action is directed to the public
in general and may be of particular
interest to those involved in the
manufacture, processing, distribution,
use, and disposal of the chemical being
evaluated, related industry trade
organizations, non-governmental
organizations with an interest in human
and environmental health, state and
local governments, Tribal Nations, and/
or those interested in the assessment of
risks involving chemical substances and
mixtures regulated under TSCA. As
such, the Agency has not attempted to
describe all the specific entities that this
action might apply to. If you need help
determining applicability, consult the
technical contact listed under FOR
FURTHER INFORMATION CONTACT.
B. What is the Agency’s authority for
taking this action?
The Agency is conducting this risk
evaluation under TSCA section 6, 15
U.S.C. 2605, which requires that EPA
conduct risk evaluations on chemical
substances and identifies the minimum
components EPA must include in all
chemical substance risk evaluations.
Each risk evaluation must be conducted
consistent with the best available
science, be based on the weight of the
scientific evidence, and consider
reasonably available information.
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Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
15 U.S.C. 2625(h), (i), and (k). See also
the implementing procedural
regulations at 40 CFR part 702. For more
information about the TSCA risk
evaluation process for existing
chemicals, go to https://www.epa.gov/
assessing-and-managing-chemicalsunder-tsca.
C. What action is the Agency taking?
EPA is announcing the availability of
and seeking public comment on a draft
risk evaluation under TSCA for DCHP
(CASRN 84–61–7). The purpose of risk
evaluations under TSCA is to determine
whether a chemical substance presents
an unreasonable risk of injury to health
or the environment, without
consideration of costs or non-risk
factors, including unreasonable risk to
potentially exposed or susceptible
subpopulations identified as relevant to
the risk evaluation by EPA, under the
conditions of use. This draft risk
evaluation is consistent with the best
available science, based on the weight of
scientific evidence, and considers
reasonably available information. EPA
has preliminarily determined that DCHP
poses unreasonable risk to human
health.
D. What should I consider as I prepare
my comments?
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 information that
you claim to be CBI. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR parts 2 and 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.
II. Background
ddrumheller on DSK120RN23PROD with NOTICES1
A. What is DCHP?
DCHP is a common chemical name for
the chemical substance 1,2benzenedicarboxylic acid, 1,2dicyclohexyl ester (CASRN 84–61–7).
DCHP is a granular solid at room
temperature that is produced by the
esterification of phthalic anhydride with
cyclohexanols. It is primarily used as a
plasticizer in adhesives and plastic and
rubber products and resins for
consumer, commercial, and industrial
applications.
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B. Why is EPA evaluating this chemical
under TSCA?
In December 2019, EPA announced its
designation of DCHP as a high-priority
substance for risk evaluation under
TSCA (Ref. 1). A draft scope of the
DCHP risk evaluation was published in
April 2020 (Ref. 2), and after receiving
public comment, EPA issued the final
scope of the DCHP risk evaluation in
September 2020 (Ref. 3).
The Agency has evaluated the health
and environmental risks of DCHP under
TSCA section 6. Laboratory animal data
suggest that developmental toxicity,
specifically androgen insufficiency
(phthalate syndrome), is the most
sensitive and robust non-cancer hazard
for DCHP. The Agency included DCHP
for cumulative risk assessment along
with five other phthalate chemicals that
also cause effects on laboratory animals
consistent with phthalate syndrome
(Ref. 4). Notably, assessments by Health
Canada, U.S. CPSC, European
Chemicals Agency (ECHA), and the
Australian National Industrial
Chemicals Notification and Assessment
Scheme (NICNAS) have reached similar
conclusions regarding the effects of
DCHP on development and have also
conducted cumulative risk assessments
of phthalates based on these chemicals’
shared ability to cause phthalate
syndrome. Further, independent, expert
peer reviewers endorsed EPA’s proposal
to conduct a cumulative risk assessment
of phthalates under TSCA during the
May 2023 meeting of the Science
Advisory Committee on Chemicals
(SACC) because doing so represents the
best available science. In this draft risk
evaluation, EPA has evaluated
cumulative exposure to phthalates for
the U.S. civilian population using
human biomonitoring data. These
phthalate exposures to the general U.S.
civilian population cannot be attributed
to specific conditions of use or other
sources. This non-attributable
cumulative exposure and risk,
representing that of the national
population, was taken into
consideration by EPA in reaching its
preliminary determination of
unreasonable risk of injury of human
health for DCHP. Had EPA not taken
this into consideration, it could have
understated the unreasonable risk of
injury to human health for DCHP.
In this draft risk evaluation, EPA has
preliminarily determined that DCHP
presents an unreasonable risk of injury
to human health under the conditions of
use (COUs). Of the 24 COUs that EPA
evaluated, 9 COUs have risk estimates
that raise concerns for workers’
exposure to DCHP, and no COUs that
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raise such concerns for consumers or
the general population. In its draft
evaluation, EPA’s protective, screeninglevel approaches demonstrated that
DCHP does not pose risk to the
environment.
After this draft risk evaluation is
informed by public comment and
independent, expert peer review advice,
EPA will issue a final risk evaluation
that includes its determination as to
whether DCHP presents unreasonable
risk to health or the environment under
the TSCA COUs. EPA also continues to
work on the draft risk evaluations of five
additional high-priority chemical
substance phthalates.
III. Request for Comment
EPA seeks feedback on the assessment
of risk presented in the draft risk
evaluation, a copy of which is available
in the docket, and encourages all
potentially interested parties, including
individuals, governmental and nongovernmental organizations, non-profit
organizations, academic institutions,
research institutions, and private sector
entities to comment on the draft risk
evaluation. To the extent possible, the
Agency asks commenters to please cite
any public data related to or that
supports comments, and to the extent
permissible, describe any supporting
data that is not publicly available.
IV. Next Steps
In its risk evaluation, EPA must
determine whether the chemical
presents an unreasonable risk to health
or the environment under the
chemical’s conditions of use. These
factors include risks to subpopulations
who may be at greater exposure or
susceptibility than the general
population, such as children and
workers. TSCA prohibits EPA from
considering non-risk factors (e.g., costs/
benefits) in making its risk
determination.
If EPA determines that a chemical
substance presents an unreasonable risk
to health or the environment, the
chemical substance must immediately
move to risk management rulemaking
action under TSCA. At the risk
management stage, EPA is required to
implement, via regulation, regulatory
restrictions on the manufacture,
processing, distribution, use or disposal
so the chemical substance no longer
presents an unreasonable risk. EPA is
given a range of risk management
options under TSCA, including labeling,
recordkeeping or notice requirements,
actions to reduce human exposure or
environmental release, and a ban of the
chemical substance or of certain uses.
Like the prioritization and risk
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Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
evaluation processes, there is an
opportunity for public comment on any
proposed risk management actions.
V. References
The following is a listing of the
documents that are specifically
referenced in this document. The docket
includes these documents and other
information considered by EPA,
including documents that are referenced
within the documents that are included
in the docket, even if the referenced
document is not physically located in
the docket. For assistance in locating
these other documents, please consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
1. EPA. High-Priority Substance
Designations Under the Toxic Substances
Control Act (TSCA) and Initiation of Risk
Evaluation on High-Priority Substances;
Notice of Availability. Federal Register. 84
FR 71924, December 30, 2019 (FRL–10003–
15).
2. EPA. Draft Scopes of the Risk
Evaluations To Be Conducted for Seven
Chemical Substances Under the Toxic
Substances Control Act; Notice of
Availability. Federal Register. 85 FR 22733,
April 23, 2020 (FRL–10008–05).
3. EPA. Final Scopes of the Risk
Evaluations To Be Conducted for Twenty
Chemical Substances Under the Toxic
Substances Control Act; Notice of
Availability. Federal Register. 85 FR 55281,
September 4, 2020 (FRL–10013–90).
4. EPA. Cumulative Risk Assessment
Under the Toxic Substances Control Act.
EPA website at https://www.epa.gov/
assessing-and-managing-chemicals-undertsca/cumulative-risk-assessment-under-toxicsubstances#.
Authority: 15 U.S.C. 2601 et seq.
Dated: December 30, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2025–00137 Filed 1–6–25; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2024–0061; FRL–11680–11–
OCSPP]
ddrumheller on DSK120RN23PROD with NOTICES1
Pesticide Product Registration;
Receipt of Applications for New Uses
(November 2024)
Rodenticide Act (FIFRA), EPA is hereby
providing notice of receipt and
opportunity to comment on these
applications.
Comments must be received on
or before February 6, 2025.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2024–0061,
through the Federal eRulemaking Portal
at https://www.regulations.gov. Follow
the online instructions for submitting
comments. 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 and visiting
the docket, along with more information
about dockets generally, is available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Madison H. Le, Biopesticides and
Pollution Prevention Division (BPPD)
(7511M), main telephone number: (202)
566–1400, email address:
BPPDFRNotices@epa.gov. The mailing
address for each contact person is Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001.
As part of the mailing address, include
the contact person’s name, division, and
mail code.
SUPPLEMENTARY INFORMATION:
DATES:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
SUMMARY: EPA has received applications information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
to register new uses for pesticide
products containing currently registered disk or CD–ROM as CBI and then
identify electronically within the disk or
active ingredients. Pursuant to the
CD–ROM the specific information that
Federal Insecticide, Fungicide, and
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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is claimed as CBI. In addition to one
complete version of the comment that
includes 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.
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.
II. Registration Applications
EPA has received applications to
register new uses for pesticide products
containing currently registered active
ingredients. Pursuant to the provisions
of FIFRA section 3(c)(4) (7 U.S.C.
136a(c)(4)), EPA is hereby providing
notice of receipt and opportunity to
comment on these applications. Notice
of receipt of these applications does not
imply a decision by the Agency on these
applications.
Notice of Receipt—New Uses
EPA Registration Number: 88847–7.
Docket ID number: EPA–HQ–OPP–
2024–0576. Applicant: Vestaron
Corporation, 4025 Stirrup Creek Drive,
Suite 400, Durham, NC 27703 USA.
Active ingredient: U1-AGTX-Ta1b-qa.
Product type: Insecticide. Proposed use:
Outdoor Terrestrial Use. Contact: BPPD.
Authority: 7 U.S.C. 136 et seq.
Dated: December 19, 2024.
Kimberly Smith,
Acting Director, Information Technology and
Resources Management Division, Office of
Program Support.
[FR Doc. 2025–00096 Filed 1–6–25; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL MARITIME COMMISSION
[Docket No. FMC–2024–0025]
Policy Statement on Class Action
Complaints
Federal Maritime Commission.
Notice of availability.
AGENCY:
ACTION:
The Federal Maritime
Commission (Commission) is issuing
this document to advise the public of
the availability of a new policy
statement. The policy statement
explains that private parties are not
precluded from bringing class action
complaints at the Commission.
DATES: Policy statement On Class Action
Complaints announced in this
document was issued on January 2,
2025.
SUMMARY:
E:\FR\FM\07JAN1.SGM
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]]>Agencies
[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1125-1127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00137]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0504; FRL-12481-01-OCSPP]
Dicyclohexyl phthalate (DCHP); Draft Risk Evaluation Under the
Toxic Substances Control Act (TSCA); Notice of Availability and Request
for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or Agency) is
announcing the availability of and seeking public comment on a draft
risk evaluation under the Toxic Substances Control Act (TSCA) for
Dicyclohexyl phthalate (DCHP) (1,2-benzenedicarboxylic acid, 1,2-
dicyclohexyl ester) (CASRN 84-61-7). The purpose of risk evaluations
under TSCA is to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment, without
consideration of costs or other non-risk factors, including
unreasonable risk to potentially exposed or susceptible subpopulations
identified as relevant to the risk evaluation by EPA, under the
conditions of use. EPA has used the best available science to prepare
this draft risk evaluation and to preliminarily determine that DCHP
poses unreasonable risk to human health.
DATES: Comments must be received on or before March 10, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0504, online at https://www.regulations.gov. Follow the online instructions for submitting
comments. 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 and visiting the docket, along with more information about
dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Chemical specific information: Claire Brisse, Existing Chemical
Risk Management Division (7404M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: (202) 564-9004; email
address: [email protected].
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
particular interest to those involved in the manufacture, processing,
distribution, use, and disposal of the chemical being evaluated,
related industry trade organizations, non-governmental organizations
with an interest in human and environmental health, state and local
governments, Tribal Nations, and/or those interested in the assessment
of risks involving chemical substances and mixtures regulated under
TSCA. As such, the Agency has not attempted to describe all the
specific entities that this action might apply to. If you need help
determining applicability, consult the technical contact listed under
FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
The Agency is conducting this risk evaluation under TSCA section 6,
15 U.S.C. 2605, which requires that EPA conduct risk evaluations on
chemical substances and identifies the minimum components EPA must
include in all chemical substance risk evaluations. Each risk
evaluation must be conducted consistent with the best available
science, be based on the weight of the scientific evidence, and
consider reasonably available information.
[[Page 1126]]
15 U.S.C. 2625(h), (i), and (k). See also the implementing procedural
regulations at 40 CFR part 702. For more information about the TSCA
risk evaluation process for existing chemicals, go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.
C. What action is the Agency taking?
EPA is announcing the availability of and seeking public comment on
a draft risk evaluation under TSCA for DCHP (CASRN 84-61-7). The
purpose of risk evaluations under TSCA is to determine whether a
chemical substance presents an unreasonable risk of injury to health or
the environment, without consideration of costs or non-risk factors,
including unreasonable risk to potentially exposed or susceptible
subpopulations identified as relevant to the risk evaluation by EPA,
under the conditions of use. This draft risk evaluation is consistent
with the best available science, based on the weight of scientific
evidence, and considers reasonably available information. EPA has
preliminarily determined that DCHP poses unreasonable risk to human
health.
D. What should I consider as I prepare my comments?
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 information that you claim to be
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR parts 2 and 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.
II. Background
A. What is DCHP?
DCHP is a common chemical name for the chemical substance 1,2-
benzenedicarboxylic acid, 1,2-dicyclohexyl ester (CASRN 84-61-7). DCHP
is a granular solid at room temperature that is produced by the
esterification of phthalic anhydride with cyclohexanols. It is
primarily used as a plasticizer in adhesives and plastic and rubber
products and resins for consumer, commercial, and industrial
applications.
B. Why is EPA evaluating this chemical under TSCA?
In December 2019, EPA announced its designation of DCHP as a high-
priority substance for risk evaluation under TSCA (Ref. 1). A draft
scope of the DCHP risk evaluation was published in April 2020 (Ref. 2),
and after receiving public comment, EPA issued the final scope of the
DCHP risk evaluation in September 2020 (Ref. 3).
The Agency has evaluated the health and environmental risks of DCHP
under TSCA section 6. Laboratory animal data suggest that developmental
toxicity, specifically androgen insufficiency (phthalate syndrome), is
the most sensitive and robust non-cancer hazard for DCHP. The Agency
included DCHP for cumulative risk assessment along with five other
phthalate chemicals that also cause effects on laboratory animals
consistent with phthalate syndrome (Ref. 4). Notably, assessments by
Health Canada, U.S. CPSC, European Chemicals Agency (ECHA), and the
Australian National Industrial Chemicals Notification and Assessment
Scheme (NICNAS) have reached similar conclusions regarding the effects
of DCHP on development and have also conducted cumulative risk
assessments of phthalates based on these chemicals' shared ability to
cause phthalate syndrome. Further, independent, expert peer reviewers
endorsed EPA's proposal to conduct a cumulative risk assessment of
phthalates under TSCA during the May 2023 meeting of the Science
Advisory Committee on Chemicals (SACC) because doing so represents the
best available science. In this draft risk evaluation, EPA has
evaluated cumulative exposure to phthalates for the U.S. civilian
population using human biomonitoring data. These phthalate exposures to
the general U.S. civilian population cannot be attributed to specific
conditions of use or other sources. This non-attributable cumulative
exposure and risk, representing that of the national population, was
taken into consideration by EPA in reaching its preliminary
determination of unreasonable risk of injury of human health for DCHP.
Had EPA not taken this into consideration, it could have understated
the unreasonable risk of injury to human health for DCHP.
In this draft risk evaluation, EPA has preliminarily determined
that DCHP presents an unreasonable risk of injury to human health under
the conditions of use (COUs). Of the 24 COUs that EPA evaluated, 9 COUs
have risk estimates that raise concerns for workers' exposure to DCHP,
and no COUs that raise such concerns for consumers or the general
population. In its draft evaluation, EPA's protective, screening-level
approaches demonstrated that DCHP does not pose risk to the
environment.
After this draft risk evaluation is informed by public comment and
independent, expert peer review advice, EPA will issue a final risk
evaluation that includes its determination as to whether DCHP presents
unreasonable risk to health or the environment under the TSCA COUs. EPA
also continues to work on the draft risk evaluations of five additional
high-priority chemical substance phthalates.
III. Request for Comment
EPA seeks feedback on the assessment of risk presented in the draft
risk evaluation, a copy of which is available in the docket, and
encourages all potentially interested parties, including individuals,
governmental and non-governmental organizations, non-profit
organizations, academic institutions, research institutions, and
private sector entities to comment on the draft risk evaluation. To the
extent possible, the Agency asks commenters to please cite any public
data related to or that supports comments, and to the extent
permissible, describe any supporting data that is not publicly
available.
IV. Next Steps
In its risk evaluation, EPA must determine whether the chemical
presents an unreasonable risk to health or the environment under the
chemical's conditions of use. These factors include risks to
subpopulations who may be at greater exposure or susceptibility than
the general population, such as children and workers. TSCA prohibits
EPA from considering non-risk factors (e.g., costs/benefits) in making
its risk determination.
If EPA determines that a chemical substance presents an
unreasonable risk to health or the environment, the chemical substance
must immediately move to risk management rulemaking action under TSCA.
At the risk management stage, EPA is required to implement, via
regulation, regulatory restrictions on the manufacture, processing,
distribution, use or disposal so the chemical substance no longer
presents an unreasonable risk. EPA is given a range of risk management
options under TSCA, including labeling, recordkeeping or notice
requirements, actions to reduce human exposure or environmental
release, and a ban of the chemical substance or of certain uses. Like
the prioritization and risk
[[Page 1127]]
evaluation processes, there is an opportunity for public comment on any
proposed risk management actions.
V. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the person
listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. High-Priority Substance Designations Under the Toxic
Substances Control Act (TSCA) and Initiation of Risk Evaluation on
High-Priority Substances; Notice of Availability. Federal Register.
84 FR 71924, December 30, 2019 (FRL-10003-15).
2. EPA. Draft Scopes of the Risk Evaluations To Be Conducted for
Seven Chemical Substances Under the Toxic Substances Control Act;
Notice of Availability. Federal Register. 85 FR 22733, April 23,
2020 (FRL-10008-05).
3. EPA. Final Scopes of the Risk Evaluations To Be Conducted for
Twenty Chemical Substances Under the Toxic Substances Control Act;
Notice of Availability. Federal Register. 85 FR 55281, September 4,
2020 (FRL-10013-90).
4. EPA. Cumulative Risk Assessment Under the Toxic Substances
Control Act. EPA website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/cumulative-risk-assessment-under-toxic-substances#.
Authority: 15 U.S.C. 2601 et seq.
Dated: December 30, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2025-00137 Filed 1-6-25; 8:45 am]
BILLING CODE 6560-50-P
