EPA Issues Health and Safety Data Reporting Rule under TSCA

By John Kowalski, regulatory affairs lead, Supply Chain team, UL Solutions

On December 13, 2024, the U.S. Environmental Protection Agency (EPA) published a final Health and Safety Data Reporting Rule to require manufacturers and importers of certain chemical substances who fall within the North American Industry Classification System (NAICS) Subsector 325 (chemical manufacturing and allied products) or Industry Group 32411 (petroleum refineries) to submit copies and lists of unpublished health and safety studies. EPA finalized this rule using its authority under Section 8(d) of the Toxic Substances Control Act (TSCA). The rule applies to the following chemical substances.

1. 4,4’-Methylene bis(2-chloraniline), CASRN 101-14-4
2. 4-tert-octylphenol (4-(1,1,3,3- Tetramethylbutyl)-phenol), CASRN 140-66-9
3. Acetaldehyde, CASRN 75-07-0
4. Acrylonitrile, CASRN 107-13-1
5. Benzenamine, CASRN 62-53-3
6. Benzene, CASRN 71-43-2
7. Bisphenol A, CASRN 80-05-7
8. Ethylbenzene, CASRN 100-41-4
9. Naphthalene, CASRN 91-20-3
10. Vinyl Chloride, CASRN 75-01-4
11. Styrene, CASRN 100-42-5
12. Tribromomethane (Bromoform), CASRN 75-25-2
13. Triglycidyl isocyanurate, CASRN 2451-62-9
14. Hydrogen fluoride, CASRN 7664-39-3
15. N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD), CASRN 793-24-8
16. 2-Anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone), CASRN 2754428-18-5

Importantly, EPA is requiring submissions of health and safety studies from companies manufacturing the listed chemical substances, including when a company is importing the chemical substance as a pure substance or within a mixture, formulated product, or article that contains the subject chemical substance. This includes instances where the chemical substance is manufactured only as an impurity.

Data submitted in response to this rule must be submitted electronically using the TSCA Section 8(d) Health & Safety Data Reporting application within EPA’s Central Data Exchange. This rule is effective on January 13, 2025 and reporting is required by March 13, 2025.

Reference

Certain Existing Chemicals; Request To Submit Unpublished Health and Safety Data Under the Toxic Substances Control Act (TSCA); Final Rule