EPA Issues Draft Risk Evaluation for Flame Retardant TCEP
Today the U.S. Environmental Protection Agency (EPA) released its draft risk evaluation for the flame retardant Tris(2-chloroethyl) phosphate (TCEP) (CASRN 115-96-8) under the Toxic Substances Control Act (TSCA) for public comment. EPA has used the best available science to preliminarily determine that this chemical poses unreasonable risk to human health and the environment. This is the first draft risk evaluation EPA has released for the 20 High-Priority Substances prioritized in 2019. EPA has incorporated improvements to the risk evaluation process announced in 2021 into this risk evaluation including an assessment of exposure to potentially exposed and susceptible subpopulations like workers, children, and subsistence fishers.
TCEP is a chemical historically used in paints and coatings, aerospace applications, fabrics and textiles, foam seating and construction materials, and is also found in a range of goods that are imported into the U.S. TCEP has been linked to kidney cancer, as well as reproductive, neurological, developmental and kidney effects.
Although U.S. production of TCEP has decreased by about 99 percent since 2014, it is still used in the U.S. to make some paints and coatings, and also is used as a flame retardant and plasticizer for specific aerospace applications. Because TCEP is mixed into but not chemically bonded to materials, it can leach out of products and into the environment. TCEP that is released into the environment from manufacturing processes or leaching from products primarily ends up in water, sediment, soil, or dust. TCEP may leach out of materials dumped in landfills and get into ground water or surface water. It can also be released into the air.
For workers, EPA assessed both inhalation and dermal exposures and found unreasonable risk from these exposures. EPA did not assume that workers always and appropriately wear PPE, even though some facilities might be using PPE as one means to reduce workers’ exposure. EPA will consider information on use of PPE, engineering controls and other ways industry protects its workers as potential ways to address unreasonable risk during the risk management process.
EPA assessed inhalation, dermal, and ingestion exposure to consumers, and found unreasonable risk from breathing or ingesting TCEP that comes out of textiles or other products and gets into indoor air. EPA also found infants and children may be at risk if they frequently mouth products containing foam, textiles or wood that contain TCEP for long periods of time, which may prove to be conservative assumptions that do not reflect real-world exposures. A single instance of exposure, such as a child mouthing a TCEP-containing product once, does not mean an individual will definitely suffer adverse health effects.
TCEP can also accumulate in fish if they live in a stream or other waterbody with high concentrations of TCEP. EPA found unreasonable risk for people eating fish taken from TCEP-contaminated water.
These concerns are particularly notable for groups that eat higher quantities of fish, such as subsistence fishers and Tribes. Tribal populations for whom fish is important dietarily and culturally have even higher risk than the general population and subsistence fishers.
Another subpopulation EPA included in its evaluation was infants exposed through human milk (e.g. breastfeeding). EPA estimated exposure and found that infants were at less risk than their mothers.
EPA also proposes to find that TCEP presents unreasonable risk to the environment, specifically to aquatic organisms chronically exposed to TCEP through surface water and sediment.
Next Steps
Upon publication of the Federal Register notice, EPA will accept public comments on the draft risk evaluation and associated supporting documents for 60 days via docket EPA-HQ-OPPT-2023-0265 at www.regulations.gov. EPA also invites submission of more specific exposure information to help the Agency refine its risk estimates for the final risk evaluation.
The draft risk evaluation will also undergo a letter peer review by independent scientific and technical experts. Following a public call for nominations in September 2023, the biographical sketches of the candidates under consideration as prospective reviewers are available in the docket for public comment. The public comment period was originally scheduled to close on December 22, 2023 and EPA is extending the comment period until January 5, 2024. Prospective candidates will be required to submit confidential financial information to fully disclose, among other financial interests, the candidate's employment, stocks and bonds, and where applicable, sources of research support. EPA will evaluate the candidates' financial disclosure forms to assess whether there are financial conflicts of interest, appearance of a loss of impartiality, or any prior involvement with the development of the documents under consideration (including previous scientific peer review) before the candidates are considered further.
EPA will hold a virtual preparatory meeting on March 5, 2024, to review the scope and clarity of the draft charge questions. Registration information for that meeting will be published in the coming months. The letter peer review is expected to begin on March 13, 2024.
EPA will use feedback received from the letter peer review and public comments to inform the final risk evaluation. If EPA concludes in the final risk evaluation that this chemical presents unreasonable risk, the Agency will move swiftly to develop risk mitigation options to protect people and the environment.
Read the draft risk evaluation.
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