The US Environmental Protection Agency (EPA) has announced plans to extend the reporting deadlines for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA). This rule mandates that manufacturers and importers of 16 specified chemicals submit unpublished health and safety studies to EPA. These studies are critical for the agency’s efforts to prioritize, evaluate and manage chemical risks under TSCA, ensuring informed regulatory decisions to protect public health and the environment.
Originally, the deadline for submitting these reports was set for March 13, 2025. Earlier this year, EPA extended the deadline by 90 days for vinyl chloride, moving it to June 11, 2025, and by 180 days for the other 15 chemicals, setting their deadline to September 9, 2025. The forthcoming rule, however, will unify and further extend the reporting deadline for all 16 chemicals to May 22, 2026. This significant extension reflects EPA’s response to industry feedback and its commitment to facilitating compliance while maintaining robust data collection.
The extended timeline aims to address practical challenges raised by regulated entities, particularly regarding the submission process for studies containing confidential business information (CBI). As such, EPA plans to use this additional time to finalize guidance and refine templates, ensuring that companies can meet reporting requirements efficiently and accurately. This move underscores the agency’s effort to balance regulatory oversight with practical support for stakeholders navigating complex compliance obligations.
The 16 chemicals covered by this rule include a range of substances with diverse industrial applications, such as 6PPD-quinone (CASRN 2754428-18-5), used in tire manufacturing; 4,4-methylene bis (2-chloroaniline) (MBOCA) (CASRN 101-14-4), a curing agent; and bisphenol A (CASRN 80-05-7), commonly found in plastics. Other listed chemicals include acetaldehyde, acrylonitrile, benzene, ethylbenzene, hydrogen fluoride, naphthalene, styrene, tribromomethane (bromoform), vinyl chloride and several others. Each chemical presents unique health and safety considerations, making the submission of comprehensive data essential for EPA’s risk assessment processes.
Under TSCA Section 8(d), EPA has the authority to require manufacturers and importers to provide unpublished health and safety studies, which may include data on toxicology, environmental fate, or exposure risks. This information is vital for the agency’s prioritization process, which identifies chemicals for further evaluation, and for conducting risk assessments to determine whether regulatory actions, such as restrictions or bans, are necessary. The data also supports risk management measures to mitigate potential hazards posed by these substances in commerce.
The decision to extend the reporting deadline to May 2026 reflects a pragmatic approach to addressing compliance challenges while maintaining the integrity of the TSCA framework. Companies subject to this rule should use this additional time to review their obligations, prepare accurate submissions, and engage with EPA’s forthcoming guidance. Legal and compliance teams are advised to closely monitor updates from EPA, particularly regarding CBI handling, to ensure alignment with the agency’s expectations.
Significantly, this extension also highlights the EPA’s ongoing efforts to refine its chemical management processes under TSCA. By providing clearer guidance and standardized templates, the agency aims to streamline data submissions, reduce administrative burdens, and enhance the quality of information received. For businesses, this presents an opportunity to strengthen their compliance strategies and contribute to EPA’s mission of safeguarding public health and the environment through informed chemical regulation.
As the May 2026 deadline approaches, stakeholders should stay proactive in preparing their submissions and leveraging EPA resources to ensure compliance. The extended timeline offers a valuable window to address technical challenges and align with the agency’s evolving requirements, ultimately supporting a more effective and transparent chemical safety framework.
