[Federal Register Volume 89, Number 187 (Thursday, September 26, 2024)]
[Notices]
[Pages 78868-78870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22061]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0476; FRL-11109-03-OCSPP]
Tris(2-chloroethyl) Phosphate (TCEP); Risk Evaluation Under the
Toxic Substances Control Act (TSCA); Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
announcing the availability of the final risk evaluation under the
Toxic Substances Control Act (TSCA) for tris(2-chloroethyl) phosphate
(TCEP). 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
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conditions of use. The Agency used the best available science to
prepare this final risk evaluation and determined, based on the weight
of scientific evidence, that TCEP poses unreasonable risk to human
health and the environment. Under TSCA, EPA must initiate risk
management actions to address the unreasonable risk.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2018-0476, is available online
at https://www.regulations.gov. 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: Chloe O'Haire, 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) 564-6785; 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
particular interest to those involved in the manufacture (defined under
TSCA section 3(9) to include import), processing, distribution, use,
and disposal of TCEP, 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 conducted 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 the Agency
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 scientific evidence, and consider
reasonably available information, pursuant to 15 U.S.C. 2625(h), (i),
and (k). See also the implementing procedural regulations at 40 CFR
part 702.
C. What action is the Agency taking?
EPA is announcing the availability of the final risk evaluation
under TSCA for TCEP. 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. EPA has used the best
available science to prepare this final risk evaluation and based on
the weight of scientific evidence, determined that TCEP poses
unreasonable risk to human health and the environment. Upon a
determination of unreasonable risk, EPA must initiate risk management
action as required pursuant to 15 U.S.C 2605(a) to address the
unreasonable risk.
II. Background
A. What is tris(2-chloroethyl) phosphate (TCEP)?
TCEP is a chlorinated phosphate ester present as a transparent
liquid that is imported, processed, distributed, used, and disposed of
as part of industrial, commercial, and consumer conditions of use. TCEP
is primarily used as an additive flame retardant and plasticizer in
polymers used in aerospace equipment and products, and as an additive
flame retardant in paint and coating manufacturing. In the past, TCEP
was processed in many products made in the United States, including
fabrics and textiles, some types of foam, and construction materials--
some of which may still be in use today. The total aggregate annual
production volume reported for TCEP under the Chemical Data Reporting
(CDR) rule ranged from 39,682 to 158,728 pounds between 2012 and 2015,
with no CDR-qualifying reports after 2015; annual production volume of
TCEP is now somewhere below the 2020 CDR reporting threshold of 25,000
pounds, with Datamyne showing 593 pounds of TCEP imported in 2020.
B. Risk Evaluation of Tris(2-chloroethyl) Phosphate (TCEP)
In 2019, EPA announced its designation of TCEP as a high priority
substance for risk evaluation under TSCA (Ref. 1). A draft scope of the
TCEP risk evaluation was issued in April 2020 (Ref. 2), and after
receiving public comment, EPA announced the final scope of the TCEP
risk evaluation in September 2020 (Ref. 3). In June 2023, EPA proposed
a significant new use rule (SNUR) for TCEP (Ref. 4). In December 2023,
EPA released a draft risk evaluation for public comment and peer review
(Ref. 5), and issued a request for nominations of expert reviewers to
conduct a letter peer review was issued in September 2023 (Ref. 6).
The final risk evaluation of TCEP addresses comments from both the
public and letter peer review periods. The responses to peer review and
public comments, along with the final TCEP risk evaluation (Ref. 7) and
a non-technical summary (Ref. 8), are available in the docket.
For more information about the TSCA risk evaluation process for
existing chemicals, go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.
III. Unreasonable Risk Determination
EPA has determined that TCEP presents an unreasonable risk of
injury to human health and the environment under the conditions of use.
EPA has determined that the unreasonable risk to human health presented
by TCEP is due to: (1) Non-cancer effects and cancer in workers from
dermal and inhalation exposures; (2) Non-cancer effects and cancer in
consumers from ingestion, dermal, and inhalation exposures; and (3)
Non-cancer effects and cancer in the general population, including
subsistence and tribal fishers from fish consumption.
Additionally, EPA has determined that TCEP presents unreasonable
risk to the environment due to chronic effects (mortality) to aquatic
species using empirical fish data. Ten conditions of use from
importing, processing, industrial uses, commercial uses, and consumer
uses were identified to significantly contribute to the unreasonable
risk.
Consistent with the statutory requirements of TSCA section 6(a),
EPA will propose risk management regulatory actions to the extent
necessary so that TCEP no longer presents an unreasonable risk. The
Agency expects to focus its risk management action on the conditions of
use that significantly contribute to the unreasonable risk. However, it
should be noted that, under TSCA section 6(a), EPA is not limited to
regulating the specific activities found to contribute significantly to
unreasonable risk and
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may select from among a suite of risk management requirements in TSCA
section 6(a) related to manufacture (including import), processing,
distribution in commerce, commercial use, and disposal as part of its
regulatory options to address the unreasonable risk. As a general
example, EPA may regulate upstream activities (e.g., processing,
distribution in commerce) to address downstream activities (e.g.,
consumer uses) contributing significantly to unreasonable risk, even if
the upstream activities do not contribute significantly to the
unreasonable risk.
IV. 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
Thirteen Chemical Substances Under the Toxic Substances Control Act;
Notice of Availability. Federal Register. 85 FR 19941, April 9, 2020
(FRL-10007-11).
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
2020 (FRL-10013-90).
4. EPA. Flame Retardants; Significant New Uses Rules for Certain
Non-Ongoing Uses. Federal Register. Docket ID No. EPA-HQ-OPPT-2023-
0012. Federal Register. 88 FR 40728, June 22, 2023 (FRL-9430-01-
OCSPP).
5. EPA. Tris(2-chloroethyl) Phosphate (TCEP); Draft Risk Evaluation
Under the Toxic Substances Control Act (TSCA); Letter Peer Review;
Notice of Availability, Public Meeting and Request for Comment.
Federal Register. 88 FR 86894, December 15, 2023 (FRL-11109-02-
OCSPP).
6. EPA. Tris(2-chloroethyl) Phosphate (TCEP); Draft Risk Evaluation
under the Toxic Substances Control Act (TSCA); Letter Peer Review;
Request for Nominations of Expert Reviewers. Federal Register. 88 FR
67278, September 29, 2023 (FRL-11109-01-OCSPP).
7. EPA. Tris(2-chloroethyl) phosphate (TCEP); Regulation Under the
Toxic Substances Control Act (TSCA); Comment Summary and Responses.
September 2024. EPA Document ID No. EPA-740-R-24-011.
8. EPA. Non-technical Summary of the TSCA Risk Evaluation for
Tris(2-chloroethyl) Phosphate (TCEP). September 2024. EPA Document
ID No. EPA-740-S-24-003.
Authority: 15 U.S.C. 2601 et seq.
Dated: September 23, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-22061 Filed 9-25-24; 8:45 am]
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