EPA Draft Risk Evaluations Pushed to End of Summer
March 12, 2019
At the 2019 Global Chemical Regulation Conference held last week, U.S. Environmental Protection Agency (EPA) officials noted that the agency is delayed with its initial 10 chemical risk evaluations, required under the amended Toxic Substances Control Act (TSCA). Under the law, EPA is required to finalize these evaluations by December 2019. So far, the agency has published one of the risk evaluations, for the chemical Pigment Violet 29 (PV-29), and had expected to publish draft evaluations for the other nine chemicals by December 2018. But officials said that the chemical review process is longer than expected, and now the agency aims to publish the draft evaluations during Summer 2019.
EPA must conduct risk evaluations on these 10 chemicals and could impose restrictions on the use of these compounds or bans, in risk mitigation rules EPA will develop after finalizing risk evaluations.
Additionally, EPA officials who spoke at GlobalChem said that parts of its rationale for concluding that current uses of PV- 29 would not be likely to cause harm would be made public soon. Officials cited reliance on European Union REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) toxicity studies used for EPA’s PV-29 evaluation, some of which included confidential business information (CBI), as defined under REACH, but not TSCA. EPA notes that not all CBI claimed under REACH is protected under TSCA, and the agency will release studies used in its PV-29 evaluation, to the extent information is not CBI.
Notably, EPA is expected to publish its next list of 20 high priority candidate chemicals by March 22, 2019. EPA must decide at least 10 of these from the remaining TSCA workplan chemicals, although it will probably select more than 10, if not all 20, from the TSCA workplan.
Amended TSCA requires EPA conduct risk evaluations of at least 20 chemicals at any given time, from chemicals it has designated as “high priority,” after completing these initial 10 risk evaluations. EPA must use this process to, “determine whether a chemical substance presents an unreasonable risk of injury to health or the environment without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator under the conditions of use.” EPA published its final risk evaluation rule on July 20, 2017.
The final rule identifies components of an EPA risk evaluation, affecting data that stakeholders must submit and parameters for public comment during the risk evaluation process. A risk evaluation consists of: 1) a statement of scope (that includes conditions of use, a conceptual model and an analysis plan); 2) a hazard assessment; 3) an exposure assessment; 4) a risk characterization; and 5) a risk determination. (40 CFR 702.41). The rule includes a procedure for manufacturers to request a risk evaluation and criteria for EPA evaluation of requests. The rule implements statutory requirements for evaluation of data, including best available science and weight of the scientific evidence. EPA also has the option to conduct a risk evaluation on a category of chemical substances instead of a single chemical substance.
ACA has engaged with EPA during the Risk Evaluation rulemaking process, submitting comments on some of EPA’s first 10 chemicals it will evaluate, including 1,4-dioxane; PV-29; Methylene Chloride, N-Methyl pyrrolidone (NMP), Trichloroethylene (TCE); and Perchloroethylene. ACA’s comments on the intentional use of several of these compounds — for example NMP and PV-29 — as well as commenting that many of these compounds are only present at trace or residual levels, e.g., 1,4-dioxane. The remaining chemicals are asbestos, 1-Bromopropane, Carbon Tetrachloride, and Cyclic Aliphatic Bromide Cluster (HBCD).
ACA will remain engaged in the development and implementation of regulations under the amended TSCA, working on behalf of its members.
Contact ACA’s Riaz Zaman for more information.