Overview
Two of the three Toxic Substances Control Act (TSCA) Framework rules EPA Administrator Pruitt signed June 22, 2017 were published in the July 20 Federal Register. These Framework regulations impact manufacturers, importers, processors, and users of chemical substances. The final rules direct how risk assessments will be conducted, “Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act,” and how EPA will prioritize chemical substances for risk assessments, “Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act.”
The Frank R. Lautenberg Chemical Safety for the 21st Century Act enacted in June 2016, which reformed TSCA, requires that risk evaluations determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under conditions of use without consideration of costs or other non-risk factors. It also requires EPA to consider unreasonable risks to potentially exposed or susceptible subpopulations. The final rule describes EPA’s process for conducting a risk evaluation including opportunities for public review and comment. The process includes identification of the conditions of use, hazards, exposures, and any potentially exposed or susceptible subpopulations that EPA expects to consider; hazard assessment, risk assessment, risk characterization and peer review. EPA must make a determination at the end of the process that either: (1) the chemical substance does not present an unreasonable risk of injury to health or the environment under the conditions of use or; (2) that the chemical substances presents an unreasonable risk of injury to health or the environment under the conditions of use, in which case EPA must initiate a Section 6(a) rulemaking to address the risk. EPA also published the notice of availability of guidance regarding third party risk evaluations.
The prioritization rule establishes a risk-based screening process and criteria to designate existing chemical substances as either: “High-Priority Substances” requiring comprehensive risk evaluations, or “Low-Priority Substances” that do not warrant additional risk evaluation. By December 2019, EPA must designate at least 20 substances as High-Priority and at least 20 chemical substances as Low-Priority.
The TSCA Inventory reporting requirements final rule has not yet been published in the Federal Register as of this writing.
Several groups have been critical of the changes made to the final rules from the proposed rules and we will continue to monitor both the implementation of the rules and their impacts on all levels of the supply chain.