[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

[[Page 78869]]

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: 
<a href="/cdn-cgi/l/email-protection#630c0b020a11064d000b0f0c06230613024d040c15"><span class="__cf_email__" data-cfemail="dfb0b7beb6adbaf1bcb7b3b0ba9fbaafbef1b8b0a9">[email protected]</span></a>.
    For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South 
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; 
email address: <a href="/cdn-cgi/l/email-protection#792d2a3a385431160d1510171c391c0918571e160f"><span class="__cf_email__" data-cfemail="d480879795f99cbba0b8bdbab194b1a4b5fab3bba2">[email protected]</span></a>.

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

[[Page 78870]]

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]
BILLING CODE 6560-50-P


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