US EPA Mandates Health Safety Data Reporting for 16 Chemicals for Prioritization Under TSCA

On December 12, 2024, the U.S. Environmental Protection Agency (EPA) introduced a final rule under section 8(d) of the Toxic Substances Control Act (TSCA). This rule mandates manufacturers and importers of 16 specific chemicals to report data from unpublished health and safety studies to EPA. The information gathered will support EPA’s efforts to prioritize, evaluate, and manage chemical risks, to protect human health and the environment.

In addition to health and safety data, manufacturers are required to submit unpublished studies on environmental effects and exposure levels for occupational, general population, and consumer settings. The chemicals listed under this rule are:

1. 4,4-Methylene bis(2-chloraniline) (MBOCA) (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)

HISTORY:

EPA mandates companies manufacturing or importing the listed chemicals, whether as pure substances, mixtures, or components in products, to submit health and safety studies. This rule aims to enhance EPA’s understanding of environmental and toxic exposures, ensuring clean air and water for all communities.

The Toxic Substances Control Act of 1976 gives EPA the authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. Certain substances are excluded from TSCA, including food, drugs, cosmetics and pesticides.

CHEMICALS UNDERGOING PRIORITIZATION:

The chemicals listed in the final rule are of particular interest because they are either undergoing prioritization for high-priority designation for risk evaluation or are expected to be candidates in the near future. In July 2024, EPA proposed to designate five chemicals as High-Priority Substances: MBOCA, Acetaldehyde, Acrylonitrile, Benzenamine, and Vinyl Chloride, all linked to cancer and used in plastic production.

Additionally, 11 chemicals are slated for the next round of prioritization beginning in December 2024, including Benzene, Bisphenol A, Ethylbenzene, Styrene, and 6PPD-quinone. Eight of these are part of the 2014 TSCA Work Plan, a list of chemicals identified for further assessment based on hazards and exposure potential.

6PPD reacts with ozone to form 6PPD-quinone, a chemical highly toxic to coho salmon in stormwater. EPA is collecting more data on both substances under TSCA, with public comments on associated risks due by January 21, 2025. Hydrogen fluoride, while not on the TSCA Work Plan, is under review due to stakeholder interest. This rule will expand EPA’s knowledge for potential prioritization.

The final rule underscores EPA’s commitment to transparency and data-driven chemical management. Stakeholders are encouraged to review the final rule for details.