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Final rule extension gives stakeholders time to prepare for chemical risk evaluations

In December 2024, the U.S. Environmental Protection Agency launched a  requiring stakeholders to fulfill reporting requirements for 16 chemicals by March 13, 2025. On March 6, just days before the original March 13 deadline, EPA that it intends to extend the final rule's reporting deadline to June 11 for vinyl chloride and Sept. 9 for the other 15 chemicals identified in the final rule. 

Under the December 2024 final rule, manufacturers and importers of the 16 chemical substances (listed below) are required to submit unpublished health and safety studies to EPA to inform the agency's "actions in carrying out its responsibilities pursuant to TSCA, including prioritization, risk evaluation, and risk management." For importers the final rule applies if they are importing any of the 16 chemicals as a pure substance or as part of a mixture, formulated product, or article. 

Identified chemicals include:

• 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)
• Vinyl chloride (CASRN 75-01-4)

Gather data now

While EPA relies on research data from the organizations and companies that use these chemicals to formulate their chemical risk evaluations and, ultimately, inform regulations, collecting these data can be challenging for stakeholders. For some chemicals, for example, EPA is likely to require very low detection limits for inhalation exposure sampling, which can create sampling and analytical challenges. EPA may also require that substantial supporting documentation be provided alongside any submitted exposure data.

Reviewing current exposure data, understanding how EPA may use your data, and gathering additional information as quickly as possible can save both time and money for stakeholders. Be prepared by:

• Auditing chemical exposure data to identify gaps
• Ensuring the collection of exposure data is properly documented
• Supplementing exposure data where needed, which may require the use of more sensitive sampling and analytical methods
• Gathering information on toxicology, epidemiology, and industrial hygiene related to any TSCA chemicals used or produced