Under Section 8(d) of the Toxic Substances Control Act (TSCA), manufacturers and importers are required to submit unpublished health and safety studies for specified chemicals to support EPA’s chemical risk prioritization and management.
Key Details
• Original Deadline: March 13, 2025
• Previous Extensions:
o Vinyl chloride extended to June 11, 2025
o Other 15 chemicals extended to September 9, 2025
• New Unified Deadline: May 22, 2026 for all 16 chemicals
• Reason for Extension:
o Industry feedback highlighting practical challenges
o Need to finalize guidance and templates, especially for submissions containing Confidential Business Information (CBI)
o EPA’s effort to balance compliance facilitation with robust data collection
Chemicals Covered (Selection)
• 6PPD-quinone (CASRN 2754428-18-5) – tire manufacturing
• 4,4-methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4) – curing agent
• Bisphenol A (CASRN 80-05-7) – plastics
• Acetaldehyde
• Acrylonitrile
• Benzene
• Ethylbenzene
• Hydrogen fluoride
• Naphthalene
• Styrene
• Tribromomethane (bromoform)
• Vinyl chloride
Importance of Reporting
• Provides EPA with critical unpublished data on toxicology, environmental fate, and exposure risks.
• Supports chemical prioritization and risk assessment under TSCA.
• Enables risk management decisions to protect public health and the environment.
Compliance Recommendations
• Use the extended timeframe to:
o Review study inventories and reporting obligations
o Prepare accurate and complete submissions
o Engage with upcoming EPA guidance, especially on CBI handling
o Coordinate with legal and compliance teams to ensure readiness
• Monitor EPA updates closely as the May 2026 deadline approaches.
EPA’s Commitment
• Streamlining the submission process with finalized templates and guidance.
• Reducing administrative burdens while maintaining data integrity.
• Enhancing chemical safety through informed regulatory decisions.
Reach out to our regulation experts on chemical and product regulatory compliances