Tris(2-chloroethyl) Phosphate (TCEP); Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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 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.

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 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.

[FR Doc. 2024-22061 Filed 9-25-24; 8:45 am]

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