EPA Announces Schedule for TSCA Risk Evaluations of Phthalates

Released December 10, 2024

The U.S. Environmental Protection Agency (EPA) is announcing its schedule for releasing Toxic Substances Control Act (TSCA) draft risk evaluations and supporting documents for five phthalate chemicals: benzyl butyl phthalate (BBP), dibutyl phthalate (DBP), di(2-ethylhexyl) phthalate (DEHP), diisobutyl phthalate (DIBP), and dicyclohexyl phthalate (DCHP). EPA will also release a draft cross-phthalate technical support document for human health benchmark dose analysis, cancer analysis, and cumulative risk analysis for BBP, DBP, DEHP, DIBP, DCHP, and di-isononyl phthalate (DINP). Separately, EPA will soon release final risk evaluations for di-isodecyl phthalate (DIDP) and DINP. 

Phthalates are primarily used as plasticizers in polyvinyl chloride (PVC) products and in adhesives, sealants, paints, coatings, rubbers, and other applications. Because of their widespread use in industrial and consumer products, people can be exposed to many phthalates. Phthalates have been found in food and have also been measured in human blood samples. Numerous laboratory animal studies have demonstrated that prenatal phthalate exposure can impact male development and reproduction, in a phenomenon known as “phthalate syndrome” (e.g., decreased fetal testicular testosterone, male reproductive tract malformations, male nipple retention, and decreased male fertility). The U.S. Consumer Product Safety Commission, the National Academies of Sciences, Engineering, and Medicine, and Health Canada have all conducted cumulative risk analyses of phthalate syndrome, and EPA is thus using this best available science to do the same in support of the individual chemical risk evaluations. 

Last week, EPA announced it was seeking public nominations of scientific and technical experts that EPA can consider for ad hoc reviewers assisting the Agency’s Science Advisory Committee on Chemicals (SACC) with the peer review of the Agency's draft risk evaluations and supporting documents for phthalates.  

EPA plans to release the final risk evaluations for DIDP and DINP in the coming weeks.  EPA released the draft risk evaluation for DIDP and draft human health hazard assessment for DINP for public comment and peer review in May 2024 ahead of a July 2024 SACC. Subsequently, EPA released the draft risk evaluation for DINP in August 2024.   EPA is incorporating feedback received from public comments and the SACC into these final risk evaluations, and, as applicable, into the draft risk evaluations for the other five phthalates. 

In late December, EPA anticipates releasing the draft risk evaluation for DCHP and its associated technical support documents for public comment. EPA will release the cross-phthalate cumulative risk analysis technical support document at the same time. Beginning in January 2025 and over the following months, EPA expects to release all the remaining technical support documents for BBP, DBP, DEHP, and DIBP into their chemical-specific dockets (see table below) as they are available. The required 60-day public comment period will officially begin when each chemical’s full draft risk evaluation is released into its docket.  

Finally, in the first quarter of 2025, EPA will post all the risk evaluation documents relevant to the SACC peer review and the draft peer review charge questions to the SACC docket (EPA-HQ-OPPT-2024-0551) on regulations.gov. At that time, EPA will open the SACC docket for public comments for the SACC’s consideration. The SACC will only be asked to consider the public comments posted to the SACC docket in its peer review while EPA will consider all comments received across all chemical-specific and the SACC dockets. 

The formal 60-day public comment period for each chemical risk evaluation will begin when that chemical’s full draft risk evaluation, including all technical support documents, the risk characterization and the risk determination, is announced in the Federal Register and posted to the chemical-specific docket. EPA will announce when each chemical's complete draft risk evaluation has been posted to its docket. See table below for each chemical’s docket number.  

The final risk evaluations for DCHP, DIBP, DBP, BBP, and DEHP will be released by December 2025 per the recent consent decree. 

Release Schedule