TSCA 8(d) Health and Safety Data Reporting Rule Updates

Under TSCA section 8(d), EPA has the authority to promulgate rules to require producers, importers, and (if specified) processors of a chemical substance or mixture to submit lists and/or copies of unpublished (both ongoing and completed) health and safety studies. In 2024 EPA finalized this Reporting Rule. Health and safety studies sought by this action inform EPA actions in carrying out its responsibilities pursuant to TSCA, including prioritization, risk evaluation, and risk management. Below is a list of updates made to this rule.

Rule Updates

March 2026 Proposed Rule

On March 30, 2026, EPA proposed to adjust the reporting deadline to allow time to reconsider the rule's requirements and confirm they effectively capture data necessary for rigorous, gold standard scientific evaluation. The proposal would extend the reporting deadline to May 21, 2027. Read the proposed rule to extend the reporting deadline.

March 2025 Interim Final Rule

On March 13, 2025, EPA published an Interim final rule to extend the reporting deadlines under TSCA 8(d) Health and Safety Reporting Rule. This extension responded to stakeholder concerns that the original March 2025 deadline was challenging due to the effort required to identify and submit health and safety data. Under this interim action, the reporting deadline for vinyl chloride was extended to June 11, 2025, and the deadline for the other 15 chemicals was extended to September 9, 2025. This publication provided an extension of data submission while giving companies additional time to prepare accurate and complete submissions. This interim extension preceded the June 2025 final rule. Read the Interim Final Rule

June 2025 Final Rule

On June 5, 2025, EPA announced a rule to extend the reporting deadline to May 22, 2026, for all 16 chemicals covered under this rule. Read the final rule to extend these deadlines.

2023 Addition of 16 Substances

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),
Tribromomethane (Bromoform) (CASRN 75-25-2),
Triglycidyl isocyanurate (CASRN 2451-62-9), and
Vinyl Chloride (CASRN 75-01-4).

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.

See the proposed rule.

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.

See the Correction to Response to Comments.

2021 Addition of 20 High-Priority Substances and 30 Organohalogen Flame Retardants

In 2021 EPA published a final rule requiring manufacturers (including importers) of 50 specified chemicals to report certain lists and copies of unpublished health and safety studies to EPA. The chemicals subject to this rule are (1) 20 chemicals designated by EPA as high-priority substances for risk evaluation and (2) 30 organohalogen flame retardants being evaluated for health risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). The original deadline for submissions to the TSCA Health and Safety Data Reporting rule was September 27, 2021. EPA filed a Federal Register Notice, amending the deadline to December 1, 2021 for 20 of the 50 chemical substances (High Priority Chemicals), and to January 25, 2022 for 30 of the 50 chemical substances (organohalogen flame retardants).

Read the final rule.

The chemicals subject to this rule (1) 20 chemicals designated by EPA as high-priority substances for risk evaluation under TSCA section 6(b). and (2) 30 organohalogen flame retardants being evaluated for health risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA).