USA Regulatory News

Update  The U.S. Environmental Protection Agency (EPA) has announced a further extension of the reporting deadline for unpublished health and safety data on 16 chemicals under TSCA Section 8(d). T...

Update 

The U.S. Environmental Protection Agency (EPA) has announced a further extension of the reporting deadline for unpublished health and safety data on 16 chemicals under TSCA Section 8(d). The new deadline for all substances is now May 22, 2026. 

This extension gives EPA additional time to finalize guidance and address industry concerns, particularly around submissions involving confidential business information. The chemicals affected include benzene, bisphenol A, styrene, vinyl chloride, among others under consideration for TSCA risk evaluation. 

These reports will support EPA’s ongoing chemical prioritization and risk management efforts. 

Original text 

In response to stakeholder requests, the U.S. Environmental Protection Agency (EPA) has announced an extension of the reporting deadlines under the Toxic Substances Control Act (TSCA) Health and Safety Data Reporting Rule. The rule mandates manufacturers and importers of 16 specified chemical substances to submit lists and copies of unpublished health and safety studies to EPA.   

Extended Reporting Deadline  

The original reporting deadline for all 16 chemical substances was March 13, 2025. However, EPA has now extended the deadlines as follows:  

• Vinyl chloride – New deadline: June 11, 2025  

• Remaining 15 chemical substances – New deadline: September 9, 2025 

The Environmental Protection Agency (EPA) has proposed extending the compliance deadlines under the Toxic Substances Control Act (TSCA) for certain entities regulated for their use of methylene chlori...

The Environmental Protection Agency (EPA) has proposed extending the compliance deadlines under the Toxic Substances Control Act (TSCA) for certain entities regulated for their use of methylene chloride. The 18-month extension specifically applies to non-federal laboratories that are not owned or operated by federal agencies or contractors working on behalf of the federal government, under the Workplace Chemical Protection Program (WCPP) and related record keeping requirements. 

Harmonizing Compliance Deadlines 

EPA has proposed this extension to standardize the compliance deadlines for all laboratories, —both federal and non-federal, so that they follow the timeline currently applied to federal agencies and their contractors. The change is intended to prevent interruptions to essential work performed by laboratories, such as monitoring environmental conditions at cleanup sites, supporting wastewater treatment processes, and conducting academic research. These activities, especially those handled by non-federal labs, play a crucial role in helping EPA fulfill its goal of safeguarding air and water quality and ensuring responsible waste management.  

Public Consultation and Further Information 

For more information, see the FEDERAL REGISTER notice announcing the proposed rule here.  

Earlier actions associated with reference G/TBT/N/USA/1988 are filed under Docket Number EPA-HQ-OPPT-2020-0465. This docket can be accessed on Regulations.gov at https://www.regulations.gov/docket/EPA-HQ-OPPT-2020-0465/document, where all key documents, supporting materials, and public comments are available. WTO Members and their stakeholders are encouraged to submit comments to the U.S. TBT Enquiry Point. Any comments received by 4:00 p.m. Eastern Time on 26 June 2025 will be forwarded to the EPA and included in the public docket, provided they fall within the official comment period. 

The U.S. Environmental Protection Agency (EPA) has released new guidance materials to help companies meet updated requirements for submitting new chemical information under the Toxic Substances Contro...

The U.S. Environmental Protection Agency (EPA) has released new guidance materials to help companies meet updated requirements for submitting new chemical information under the Toxic Substances Control Act (TSCA). These requirements were introduced in a final rule published in December 2024. 

Interim Submission Process While CDX Updates Are Pending 

The final rule now requires companies to include more detailed information in their new chemical submissions—if that information is known or can reasonably be found by the company. 

While EPA is working to update its Central Data Exchange (CDX) system to handle the new requirements, those system changes are not yet complete. In the meantime, companies must use the current CDX system. To help with this, EPA has issued clear, temporary instructions on how to include the required information using the existing submission process. 

Future Implementation and Stakeholder Training 

Once the updated CDX system is ready, EPA will inform and train stakeholders on how to use the system. At that point, the temporary instructions will no longer apply. 

For more details, visit the final rule docket and EPA’s technical support page for PMN submissions. 

On May 12, 2025, the U.S. Environmental Protection Agency (EPA) issued an interim final rule delaying the start of the PFAS reporting period under the Toxic Substances Control Act (TSCA) Section 8(a)(...

On May 12, 2025, the U.S. Environmental Protection Agency (EPA) issued an interim final rule delaying the start of the PFAS reporting period under the Toxic Substances Control Act (TSCA) Section 8(a)(7). Originally set to begin on July 11, 2025, the reporting window will now open April 13, 2026. This extension allows the Agency more time to finalize and test the data collection system. 

New Deadlines

General manufacturers and importers: October 13, 2026 

Small manufacturers (article importers only): April 13, 2027 

The submission delay takes effect immediately, but EPA will accept public comments on it for 30 days. The Agency may also revisit other parts of the PFAS reporting rule and will review all comments together. Feedback can be submitted at www.regulations.gov (Docket: EPA-HQ-OPPT-2020-0549). 

The agency may also propose changes to other parts of the rule in the near future. 
For more information about the rule, please visit US EPA finalises rule requiring reporting of PFAS data. 

On 4 April 2025, the United States notified the World Trade Organization (WTO) of a proposed rule to establish Significant New Use Rules (SNURs) for 37 chemical substances under the Toxic Substances C...

On 4 April 2025, the United States notified the World Trade Organization (WTO) of a proposed rule to establish Significant New Use Rules (SNURs) for 37 chemical substances under the Toxic Substances Control Act (TSCA). The proposal was published by the U.S. Environmental Protection Agency (EPA) in the Federal Register under docket number EPA-HQ-OPPT-2024-0332. 

Scope and Regulatory Background 

The SNURs aim to require manufacturers, importers, and processors to submit a Significant New Use Notification (SNUN) at least 90 days before engaging in any activity identified as a significant new use. This enables EPA to evaluate any potential health or environmental risks before such uses begin. 

The affected substances, which were previously reviewed under Premanufacture Notices (PMNs), are used in various applications, including polymers, coatings, adhesives, surfactants, perfumes, UV-curable resins, and catalysts. The proposed SNURs seek to limit uses that deviate from original risk assessments. 

What’s Next? 

The public comment period ended on 6 May 2025. EPA will now review the submitted feedback and may revise the proposal before publishing a final rule. Once finalized, the rule will be incorporated into 40 CFR Part 721 and compliance will be legally binding. 

Stakeholders, particularly those in the chemical manufacturing and import sectors, are advised to monitor for updates and prepare for potential regulatory obligations once the final rule is issued. 

Introduced in the 2025–2026 legislative session, California Senate Bill 682 (SB 682) aims to address environmental and public health concerns associated with perfluoroalkyl and polyfluoroalkyl subst...

Introduced in the 2025–2026 legislative session, California Senate Bill 682 (SB 682) aims to address environmental and public health concerns associated with perfluoroalkyl and polyfluoroalkyl substances (PFAS). These substances are often referred to as "forever chemicals" due to their persistence in the environment and human body. 

Key Highlights of SB 682: 

1. Timeline for PFAS Restrictions: 

• January 1, 2027: Prohibition on distributing, selling, or offering for sale covered products containing intentionally added PFAS. There are exceptions for previously used products and instances where federal law preempts state regulation. 

• January 1, 2033: Broader restrictions on additional PFAS-containing products, unless deemed unavoidable by the Department of Toxic Substances Control (DTSC). 

• January 1, 2040: Further prohibitions on specific products, including refrigerants and solvents, unless exempted. 

2. Definition of Covered Products: 

The bill defines "covered products" to include a range of items such as cleaning products, cookware, dental floss, juvenile products, food packaging, and ski wax. 

3. Regulatory Framework: 

The Department of Toxic Substances Control (DTSC) must adopt regulations by January 1, 2027, to enforce these provisions. This includes establishing application fees. Once the regulations are in place, it will be illegal to distribute, sell, or offer for sale non-exempt products that contain more than allowed levels of PFAS. 

4. Compliance and Enforcement: 

Manufacturers will need to register with the DTSC and certify their compliance with PFAS prohibitions. The department will have the authority to test products, issue violations, and impose penalties for non-compliance. 

5. Transparency and Public Access: 

The DTSC will maintain a publicly available list of products deemed to have a currently unavoidable use of PFAS. This ensures transparency and enables consumers and businesses alike to make informed decisions. 

What This Means for You: 

As a business owner or stakeholder in the consumer products industry, it’s crucial to stay informed about these upcoming changes. Compliance with these regulations will not only be necessary to avoid penalties but also to align with growing consumer demand for PFAS-free and environmentally safer products. 

Next Steps: 

• Review Your Products: Assess your current product lines for PFAS content and begin planning for compliance with the new regulations. 

• Stay Informed: Keep an eye on updates from the DTSC regarding the development of the regulations and the compliance application process. 

• Engage with Stakeholders: Consider discussing these changes with your supply chain partners to ensure a smooth transition and compliance strategy. 

The U.S. Environmental Protection Agency (EPA) has finalized its Interim Decision on Ethylene Oxide (EtO), a widely used pesticide and sterilizing agent. EPA announced stronger protections to reduce c...

The U.S. Environmental Protection Agency (EPA) has finalized its Interim Decision on Ethylene Oxide (EtO), a widely used pesticide and sterilizing agent. EPA announced stronger protections to reduce cancer risk for workers and communities. EtO is used to sterilize approximately 50% of U.S. medical devices and 30% of dried herbs and spices. 

Health Risks of Ethylene Oxide 

EtO is a known human carcinogen, linked to lymphocytic leukemia, breast cancer, non-Hodgkin lymphoma, and myeloma. Workers at sterilization facilities and individuals living or working near these facilities are at the greatest risk of exposure. 

Comprehensive Risk Mitigation 

This Interim Decision complements the 2024 National Emissions Standards for Hazardous Air Pollutants (NESHAP), creating a combined approach to address EtO pollution under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Clean Air Act. EPA’s combined actions target EtO-related cancer risks, improving safety for communities and workers while ensuring the availability of sterilized medical supplies. 

Key Measures for Commercial Sterilizers 

Phased Worker Exposure Limits: 

 EPA is implementing a reduction in permissible worker exposure to ethylene oxide (EtO) in phases, lowering the limit to 0.5 ppm by 2028, 0.25 ppm by 2030, and 0.1 ppm by 2035. These limits are significantly stricter than the current OSHA standard of 1 ppm. 

New Sterilization Standards: 

 A maximum EtO concentration of 600 mg/L will be required for new medical device sterilization cycles within 10 years. If a higher concentration is needed due to device design, facilities must provide justification and maintain supporting documentation. 

Use Cancellations: 

EPA has banned the use of EtO for museum and archival materials, cosmetics, musical instruments, and beekeeping equipment immediately. Additionally, the agency will phase out the use of EtO for specific dried herbs and spices where safer, effective alternatives exist. 

Facility Safety Improvements: 

Commercial sterilization facilities must separate HVAC systems to reduce EtO exposure in areas such as offices. Continuous air monitoring and breathing zone testing will be required to assess exposure levels. Workers performing high-risk tasks such as handling EtO containers must use respirators for protection. 

Healthcare Facility Requirements: 

Healthcare facilities that use more than 10 pounds of EtO per year must install a batement devices to reduce emissions. EtO used in these facilities must be vented through exterior ventilation stacks to limit exposure. EPA considers the community risk from healthcare facilities to be minimal, given their comparatively low volumes of EtO use. 

Next Steps 

Registrants are required to submit label amendments within 60 days of publication of the Interim Decision. New safety measures will be implemented over a 2–10 year period to balance health protections with supply chain stability. EPA will also issue a Data Call-In (DCI) to collect real-world data on worker exposure at commercial sterilizers and warehouses. The agency plans to reassess the decision in eight years, which is earlier than the typical 15-year pesticide review cycle.