Health and Safety Reporting Rule Finalized for 16 Chemicals

On December 13, 2024, EPA finalized a rule under the Toxic Substances Control Act (TSCA) requiring manufacturers of 16 chemical substances to submit unpublished health and safety studies to EPA.  The agency will use this information to inform possible evaluation and regulation of these substances under TSCA section 6.

Once the rule takes effect on January 13, 2025, covered entities will have 60 days to report unpublished health and safety information, which includes environmental monitoring data, studies on environmental effects, and tests on biological, photochemical, and chemical degradation.  Manufacturers must also submit lists of planned, ongoing, and known studies, even if the studies are not in their possession.

The rule requires manufacturers to submit these studies regardless of the level at which the substances are present in the evaluated media (e.g., air, soil, water, sediment, or biota).  That is, EPA opted not to include a minimum concentration level for these substances.  Historically, EPA has exempted studies in which a listed substance was only present as an impurity.  That is not the case here.

A complete list of the 16 chemicals can be found in a previous blog post.  On December 18, 2024, EPA initiated risk evaluations for five of these substances and began the prioritization process—an initial step before risk evaluation—for another five.  More on those actions can be found here.

Update

On March 6, 2025, EPA announced in an email that the agency will issue a rule to extend the reporting deadline by 90 days to June 11, 2025, for vinyl chloride and 180 days to September 9, 2025, for the other chemicals covered under the rule.