TSCA 8(d) Health and Safety Data Reporting: Addition of 16 Substances
On this page:
Rule Summary
Update: On March 13, 2025 EPA published a rule to extend the reporting deadline 90 days to June 11, 2025, for vinyl chloride and 180 days to September 9, 2025, for the other chemicals covered under this rule. Read the final rule that extended these deadlines.
This final rule under section 8(d) of the Toxic Substances Control Act (TSCA) requires manufacturers (including importers) of 16 chemicals to report data from unpublished health and safety studies to EPA. These health and safety studies will help inform EPA’s prioritization, risk evaluation and risk management of chemicals under TSCA, furthering the Agency’s efforts to protect human health and the environment. In addition to health and safety studies, manufacturers are required to submit unpublished studies on environmental effects and occupational, general population, and consumer exposure for these chemicals. See the Compliance section below for more information on the reporting requirements.
The chemicals subject to this rule are:
- 4,4-Methylene bis(2-chloraniline) (CASRN 101-14-4),
- 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) (CASRN 140-66-9),
- Acetaldehyde (CASRN 75-07-0),
- Acrylonitrile (CASRN 107-13-1),
- Benzenamine (CASRN 62-53-3),
- Benzene (CASRN 71-43-2),
- Bisphenol A (CASRN 80-05-7),
- Ethylbenzene (CASRN 100-41-4),
- Hydrogen fluoride (CASRN 7664-39-3),
- N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine (6PPD) (CASRN 793-24-8),
- 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (CASRN 2754428-18-5),
- Naphthalene (CASRN 91-20-3),
- Styrene (CASRN 100-42-5),
- Tribomomethane (Bromoform) (CASRN 75-25-2),
- Triglycidyl isocyanurate (CASRN 2451-62-9), and
- Vinyl Chloride (CASRN 75-01-4).
Rule History
Background
In December 2023, EPA began the process to prioritize five of these 16 chemicals for risk evaluation under TSCA: Acetaldehyde, Acrylonitrile, Benzenamine, MBOCA, and Vinyl Chloride. Thus, to support the prioritization process as well as to inform risk evaluation findings on any of these substances that EPA might designate as a high-priority substance, EPA sought unpublished health and safety studies on these chemical substances. Submission of the studies were to ensure that they are available to EPA to inform any activities undertaken pursuant to TSCA section 6. Of the 16 chemical substances subject to this rule, EPA identified 15 of them as potential candidates for prioritization based on a screening process considering hazard, exposure (including uses), and persistence and bioaccumulation characteristics.
EPA accepted public comments on this rule when it was proposed. Those comments and a Response to Comment document are available at www.regulations.gov under docket EPA-HQ-OPPT- 2023-0360.
N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) and its transformation product, 6PPD-quinone are included in this rule in response to a citizens’ petition filed under TSCA section 21 regarding 6PPD and 6PPD-quinone (see EPA’s grant of the petition). Requiring the reporting of unpublished health and safety studies will support efforts to address data needs and to better understand and characterize potential risks associated with these chemicals. EPA has also issued an advance notice of proposed rulemaking (ANPRM) under Section 6 of TSCA to gather information on the potential risks associated with 6PPD and 6PPD-quinone.
See the Advanced Notice of Proposed Rulemaking.
EPA erroneously stated in the Response to Comment document for the final rule that retrospective study search dates are limited to 10 years from the date that the rule was published. In fact, the rule does not provide a 10-year limit on study search dates. To address this issue, EPA has published a correction to the docket that aligns the response with the final rule.