On June 22, 2017, the U.S. EPA announced three final rules promulgated pursuant to the recently amended Toxic Substances Control Act (TSCA). TSCA regulates the production, importation, use, and disposal of new and existing chemical substances and was amended in June 2016 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The 2016 amendments to TSCA required EPA to issue so-called framework rules by June 22, 2017.
EPA issued three framework rules intended to create an outline for assessing and managing the risk of new and existing chemicals:
- The final risk evaluation rule describes how EPA will determine whether chemicals present an unreasonable risk of injury to human health or the environment. The final rule will become effective upon publication in the Federal Register.
- The final prioritization rule describes how EPA will determine which of the existing chemicals will undergo risk evaluations and when. The rule will become effective 60 days after publication in the Federal Register.
- The final inventory update rule requires manufacturers, importers, and processors of chemical substances to provide various notices of active and inactive chemicals to EPA through an electronic reporting mechanism. The rule will become effective upon publication in the Federal Register.
EPA also released a guidance document to assist interested persons (also called external parties) in developing and submitting draft risk evaluations to EPA, and scope documents regarding the first ten chemicals that will undergo risk evaluation under the amended TSCA: asbestos, 1-bromopropane, carbon tetrachloride, 1,4-dioxane, cyclic aliphatic bromide cluster (HBCD), methylene chloride, n-methylpyrolidone, perchloroethylene, pigment violet 29, and trichloroethylene.
The final rules have garnered strong adverse reactions from environmentalists. Environmental Defense Fund’s Richard Denison has threatened a lawsuit regarding the final risk evaluation rule, claiming it “undermines the clear intent of Congress that EPA examine the full range of exposures to a chemical.” In contrast, the American Chemistry Council has commended EPA’s final rules.