The eRulemaking Program

06/05/2025 | Press release | Distributed by Public on 06/05/2025 06:40

Dibutyl Phthalate (DBP) and Diethylhexyl Phthalate (DEHP); Draft Risk Evaluations Under the Toxic Substances Control Act (TSCA); Notice of Availability

ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0503 and EPA-HQ-OPPT-2018-0433; FRL-12808-01-OCSPP]

Dibutyl Phthalate (DBP) and Diethylhexyl Phthalate (DEHP); Draft Risk Evaluations 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 the draft risk evaluations under the Toxic Substances Control Act (TSCA) for Dibutyl Phthalate (DBP) (CASRN 84-74-2) and Diethylhexyl Phthalate (DEHP) (CARSN 117-81-7). 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 under the conditions of use, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, and without consideration of costs or non-risk factors. EPA used the best available science to prepare this draft risk evaluation and to preliminarily determine, based on the weight of scientific evidence, that DBP and DEHP present unreasonable risk to health and the environment driven primarily by certain conditions of use analyzed in the draft evaluations.

DATES:

Comments must be received on or before August 4, 2025.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0503, 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:

For technical information on DBP: Carolyn Mottley, 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) 566-1955; email address: mottley.carolyn@epa.gov.

For technical information on DEHP: Dyllan Taylor, 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) 564-2913; email address: taylor.dyllan@epa.gov .

For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.

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 DBP and DEHP, 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 appropriate 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 the 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, and not consider costs or non-risk factors. 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 and seeking public comment on these draft risk evaluations conducted under TSCA for DBP and DEHP. The purpose of risk evaluation under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, and without consideration of costs or non-risk factors. EPA has used the best available science to prepare this draft risk evaluation and, based on the weight of scientific evidence, to preliminarily determine that DBP and DEHP present unreasonable risk to health and the environment driven primarily by certain conditions of use analyzed in the draft evaluations.

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 are DBP and DEHP?

DBP is a common chemical name for the chemical substance 1,2-Benzenedicarboxylic acid, 1,2-dibutylester (CASRN 84-74-2). DEHP is a common chemical name for the chemical substance 1,2-Benzenedicarboxylic acid, 1,2-bis(2-ethylhexyl) ester (CASRN 117-81-7). DBP and DEHP are manufactured (including imported), processed, distributed, and disposed as part of industrial, commercial, and consumer conditions of use. DBP and DEHP are used primarily as plasticizers in polyvinyl chloride (PVC). These phthalates are also used in adhesives, sealants, paints, coatings, rubbers, and non-PVC plastics, as well as for other applications. Between 2016 and 2019 the productions volumes of DBP and DEHP were between 1 to 10 million pounds and between 10 to 50 million pounds, respectively, based on the 2020 TSCA Chemical Data Reporting data.

B. Summary of Activities for the Risk Evaluations of DBP and DEHP

In December 2019, EPA announced its designation of DBP and DEHP as high priority substances for risk evaluation under TSCA (Ref. 1). In June 2020, EPA sought public comment on the draft scopes of the DBP and DEHP risk evaluations (Ref. 2), and, after considering public comments, issued the final scope in September 2020 (Ref. 3). These documents, other supporting documents, and public comments are in the docket established for each chemical at https://www.regulations.gov. In addition, as will be announced separately in the Federal Register , the draft risk evaluations for DBP and DEHP will also undergo peer review by the Science Advisory Committee on Chemicals (SACC) and will be included in the SACC peer review docket (Docket ID No. EPA-HQ-OPPT-2024-0551), along with other materials related to that peer review.

III. Request for Comment

EPA seeks feedback on the assessment of risk presented in the draft risk evaluations for DBP (Docket ID No. EPA-HQ-OPPT-2018-0503) and DEHP (Docket ID No. EPA-HQ-OPPT-2018-0433), which are available in the chemical specific dockets as identified, 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 evaluations. To the extent possible, the Agency asks commenters to please cite any public data related to or that support comments provided, and to the extent permissible, describe any supporting data that are not publicly available.

EPA welcomes specific input on each section of the draft risk evaluation for each chemical, and is particularly interested in comments and information related to the following topics:

  • Information on the use of personal protective equipment (PPE) and engineering controls during the manufacture, processing, and use of DBP and DEHP for each condition of use.
  • Information that could be used to replace upper-bound or screening level assumptions, particularly for the conditions of use that may significantly contribute to unreasonable risk;
  • Application of the Revised Draft Technical Support Document for the Cumulative Risk Analysis (CRA) within the individual chemical risk evaluations;
  • The use of transcriptomics data in the weight of scientific evidence for environmental hazard assessment of DBP and the environmental hazard assessment of DEHP;
  • The human health and environmental hazard endpoints used in the risk characterizations;
  • Application of a flux-limited approach to estimating dermal absorption; and
  • Approaches used to estimate chemical migration rate for ingestion via mouthing in the consumer exposure assessments.

IV. Next Steps

After consideration of comments received from the public and the SACC on the draft risk evaluations, EPA will issue final risk evaluations for DBP and DEHP. A separate forthcoming Federal Register notice will announce the peer review by the SACC.

Under TSCA section 6, EPA must determine in the final risk evaluations, based on the weight of scientific evidence, whether or not the chemicals present an unreasonable risk to health or the environment under the chemical's conditions of use. This includes consideration of risks to potentially exposed susceptible subpopulations (PESS) who may be at greater risks than the general population, such as children and workers. TSCA prohibits EPA from considering non-risk factors ( e.g., costs/benefits) during risk evaluation.

If EPA determines that a chemical presents an unreasonable risk to health or the environment, the chemical will move to risk management action under TSCA section 6(a) for the relevant conditions of use. EPA is required to implement, via regulation, regulatory restrictions on the manufacture (including import), processing, distribution, use or disposal of the chemical to eliminate the identified 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 or of certain uses. Like the prioritization and risk evaluation processes, there is an opportunity for public comment on any proposed risk management actions.

For more information about the TSCA risk evaluation process for existing chemicals, go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.

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).

Authority: 15 U.S.C. 2601 et seq.

Dated: May 30, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
[FR Doc. 2025-10200 Filed 6-4-25; 8:45 am]
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