EPA Releases Draft TSCA Risk Evaluations for Phthalates DBP and DEHP for Public Comment and Peer Review

Released June 4, 2025

Today, the U.S. Environmental Protection Agency (EPA) released its draft risk evaluations and associated technical support documents for dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP) under the Toxic Substances Control Act (TSCA) for public comment and peer review by the Science Advisory Committee on Chemicals (SACC). EPA preliminarily determined that DBP and DEHP present unreasonable risks to human health and the environment driven primarily by certain conditions of use (COUs) analyzed in the draft risk evaluations. EPA transmitted these documents to the Federal Register on May 30, 2025, pursuant to the terms of the Consent Decree the agency entered into in Community In-Power and Development Association, Inc. et al v. EPA, no. 1:23-cv-02715-DLF, a case pending in the United States District Court for the District of Columbia. Additionally, as described below, EPA is releasing documents that support the risk evaluations of DBP and DEHP and also support the three other phthalates undergoing risk evaluation, for public comment and peer review.

DBP Draft Risk Evaluation

EPA is preliminarily determining that DBP presents unreasonable risk of injury to human health based on identified risk to workers from 20 COUs, risk to consumers from four COUs, and that DBP presents an unreasonable risk to the environment from one COU. EPA did not preliminarily identify a risk of injury to human health or the environment from the other 19 COUs for DBP. For COUs with identified risk to workers, these preliminary risk determinations do not reflect the use of personal protective equipment (PPE); however, as the draft risk evaluation shows, the use of PPE may reduce exposures and mitigate risk. EPA did not preliminarily identify unreasonable risk of injury to human health for the general population for DBP from any COU. EPA did not preliminarily identify any COUs for DBP for which the addition of cumulative exposure contributed to unreasonable risk to human health.

Read the draft risk evaluation for DBP.

DEHP Draft Risk Evaluation

EPA is preliminarily determining that DEHP presents an unreasonable risk of injury to human health based on identified risk to workers from 13 COUs, and that DEHP presents an unreasonable risk to the environment from 20 COUs. After considering the risks posed under the COUs, EPA did not preliminarily identify a risk of injury to human health or the environment from the other COUs for DEHP. For COUs with identified risk to workers, these preliminary risk determinations do not reflect the use of PPE; however, as the draft risk evaluation shows, the use of PPE may reduce exposures and mitigate risk. EPA did not preliminarily identify unreasonable risk of injury to human health for the general population for DEHP from any COU. EPA did not preliminarily identify any COUs for DEHP for which the addition of cumulative exposure contributed to unreasonable risk to human health.

Read the draft risk evaluation for DEHP. 

Risk Evaluations for Related Phthalates and Cross-Cutting Documents

DBP and DEHP are part of a group of five phthalates that are currently undergoing TSCA risk evaluation. These five phthalates are DBP, DEHP, butyl benzyl phthalate (BBP), diisobutyl phthalate (DIBP), and dicyclohexyl phthalate (DCHP).

In January 2025, EPA released:

The draft risk evaluation for DCHP, available in the DCHP TSCA docket.
A draft cumulative risk analysis for all five phthalates entitled Revised Draft Technical Support Document for the Cumulative Risk Analysis of Di(2-ethylhexyl) Phthalate (DEHP), Dibutyl Phthalate (DBP), Butyl Benzyl Phthalate (BBP), Diisobutyl Phthalate (DIBP), Dicyclohexyl Phthalate (DCHP), and Diisononyl Phthalate (DINP) Under the Toxic Substances Control Act (TSCA), available in each of the five chemical’s TSCA dockets.
A technical support document (TSD) entitled Draft Meta Analysis and Benchmark Dose Modeling of Fetal Testicular Testosterone for BBP, DBP, DEHP, DIBP, and DCHP, available in each of the five chemicals’ TSCA dockets.
Physical chemistry and environmental fate, human health non-cancer hazard, and environmental hazard TSDs for DIBP, DBP, DEHP, and BBP, available in each of the four chemicals’ TSCA dockets.

Today, in addition to the draft risk evaluations for DBP and DEHP, EPA is releasing a draft carcinogenicity assessment and an addendum to the draft cumulative risk for the five phthalates entitled Revised Draft Technical Support Document for the Cumulative Risk Analysis of Di(2-ethylhexyl) Phthalate (DEHP), Dibutyl Phthalate (DBP), Butyl Benzyl Phthalate (BBP), Diisobutyl Phthalate (DIBP), Dicyclohexyl Phthalate (DCHP), and Diisononyl Phthalate (DINP) Under the Toxic Substances Control Act (TSCA). These cross-cutting documents will be posted in each of the five chemicals’ TSCA dockets as well as the peer review docket.

The draft risk evaluations for BBP and DIBP will be released to the public in July of 2025.

Public Comment and Peer Review

The chemical specific TSCA dockets for each of the five phthalates are:

EPA will accept public comments on the draft risk evaluation for DBP and DEHP via their TSCA dockets for 60 days, until August 4, 2025. EPA is also seeking public comments on the two cross-cutting documents released today in the DBP and DEHP dockets. EPA is seeking comment on all aspects of these draft documents.

EPA will hold a virtual public meeting of the SACC to peer review all documents released thus far related to the risk evaluation of the five phthalates, including the draft risk evaluations for DBP, DEHP and DCHP as well as cross-cutting documents related to all five chemicals. The meeting will take place on August 4 – 8, 2025. EPA will soon publish a Federal Register notice with additional information on how to register for the meeting and submit your written and oral comments. The draft charge questions will be made available in the peer review docket by June 16, 2025

If the public would like their comments considered by the SACC during the peer review meeting, they must be submitted by July 21, 2025, to the peer review docket EPA-HQ-OPPT-2024-0551. All comments received in either the peer review docket or the TSCA dockets will be considered by the agency in the development of the final risk evaluations.

Because the SACC is reviewing several TSDs that will support the risk evaluations for BBP and DIBP, EPA will consider the SACC recommendations from this upcoming peer review when developing the risk evaluations and unreasonable risk determinations for these two chemicals. Therefore, EPA does not expect the need for an additional peer review of the forthcoming risk evaluations for BBP and DIBP.

Next Steps

After the agency has considered public comments and the independent, expert peer review, EPA will issue final risk evaluations that include its determination as to whether DBP, DEHP, BBP, DIBP and DCHP present an unreasonable risk of injury to human health or the environment based on identified unreasonable risk from the COUs.

EPA Releases Draft TSCA Risk Evaluations for Phthalates DBP and DEHP for Public Comment and Peer Review

Released June 4, 2025

Chemicals under the Toxic Substances Control Act (TSCA)