EPA supplemental TSCA analysis spurs renewed discussion over 1,4-Dioxane regulation


The EPA’s supplemental analysis includes certain consumer exposures, as well as surface/ambient water exposures, to 1,4-dioxane.

The US Environmental Protection Agency (EPA) released an expanded risk evaluation for 1,4-dioxane under the Toxic Substances Control Act (TSCA) on November 19, 2020 (the Supplemental Analysis). In its original draft risk evaluation, released in June 2019, EPA preliminarily found unreasonable risks in certain circumstances for workers, but no unreasonable risks to the environment or occupational nonusers. The Supplemental Analysis expands the scope of the review to include certain consumer exposures, as well as surface/ambient water exposures. EPA initiated its Supplemental Analysis following public comments and peer review feedback to the initial draft risk evaluation.

1,4-dioxane is one of the first 10 chemicals evaluated by EPA pursuant to the 2016 amendments to the TSCA (which directed EPA to select the first 10 chemicals for evaluation from the 2014 update of the TSCA Work Plan). EPA is supposed to finalize all of the first 10 risk evaluations by the end of 2020, but so far it does not appear to be on track to meet this deadline.

1,4-dioxane is classified by EPA as a likely human carcinogen that is often used as a stabilizer in greases, waxes, paint strippers, antifreeze, and chlorinated solvents. It is also used in some consumer products, such as deodorant, cosmetics, and shampoo, where it typically results as a byproduct from ethoxylation, a process used to make the products less harsh to consumers.

Industry groups had advocated for the expansion to the risk evaluation in the hopes of preempting state rules that are set to come into effect, including most notably rules in California and New York. New York, for example, recently amended its environmental conservation law to place maximum allowable concentrations of 1,4-dioxane in cosmetics, personal care, and household cleaning products. Under the New York legislation, household cleaning products and personal care products will be subject to a limit of 1,4-dioxane of 2 parts per million (ppm) starting on December 31, 2022, and 1 ppm starting December 31, 2023, and cosmetic products will be subject to a maximum concentration of 10 ppm starting on December 31, 2022. If EPA issues a final decision that the chemicals present no unreasonable risk, states would be preempted under the TSCA from regulating 1,4-dioxane under the conditions of use the agency evaluated.

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J D Supra, 9 December 2020
; https://www.jdsupra.com/legalnews/epa-supplemental-tsca-analysis-spurs-94058/