Phthalates DBP and DEHP Present an Unreasonable Risk, EPA Drafts Say

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EPA has preliminarily determined that dibutyl phthalate (DBP) and diethylhexyl phthalate (DEHP) present an unreasonable risk to human health and the environment in separate draft risk evaluations released on June 5, 2025, under the Toxic Substances Control Act (TSCA).

Both chemicals are primarily used as plasticizers for polyvinyl chloride (PVC), according to EPA.  Chemical Data Reporting (CDR) rule data indicates that 1–10 million pounds of each was manufactured or imported into the US in 2019, the most recent year with available information.

DBP’s unreasonable risk finding was based on risks to workers from 20 conditions of use (COUs), risks to consumers from four COUs, and risks to the environment from one COU.  For the other 19 COUs, the draft risk evaluation did not identify an unreasonable risk.

DEHP’s unreasonable risk finding was based on risks to workers from 13 COUs and risks to the environment from 20 COUs.  The draft risk evaluation did not identify unreasonable risk from the remaining 23 COUs, including all evaluated consumer uses.

The drafts follow the “single determination” approach established by the Biden administration’s framework rule for risk evaluations, which provides an overall risk determination instead of separate determinations for each COU.  In March, EPA announced it would reconsider the framework rule and asked the D.C. Circuit to hold a consolidated lawsuit challenging it in abeyance.  The court granted the request on April 30.

Both drafts also incorporate findings from EPA’s first-of-its-kind cumulative risk assessment (CRA) for six phthalates as a class.  The CRA focuses on phthalate syndrome, a collection of adverse effects on the developing male reproductive system.

“By taking into account cumulative exposure and risk…EPA is confident that it is not underestimating the risk of DEHP and is reflecting the best available science,” the DEHP draft states.

EPA released the draft CRA in January alongside the agency’s draft risk evaluation for the phthalate DCHP, which also incorporated its findings.

Comments on the draft DBP and DEHP risk evaluations are due August 4, 2025.  EPA will hold a virtual public meeting of the Science Advisory Committee on Chemicals (SACC) on August 4–8 to review the drafts, as well as documents that relate to all five phthalates currently undergoing risk evaluation.

EPA’s press release for DBP and DEHP notes that draft risk evaluations for two more phthalates, BBP and DIBP, will be released in July 2025.  More on the CRA and EPA’s schedule for phthalate reviews can be found here.