USA Regulatory News

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. 

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 Safet...

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 

These extensions are intended to provide manufacturers and importers with additional time to gather and submit the required data to ensure compliance with the rule. 

For background on EPA’s health and safety data reporting for the 16 chemicals under TSCA, see the original news here. 

The U.S. Environmental Protection Agency has extended the public comment periods for two key chemical evaluations under the Toxic Substances Control Act (TSCA), allowing stakeholders additional time t...

The U.S. Environmental Protection Agency has extended the public comment periods for two key chemical evaluations under the Toxic Substances Control Act (TSCA), allowing stakeholders additional time to provide feedback on regulatory decisions for C.I. Pigment Violet 29 (PV29) and vinyl chloride. 

Extended Comment Period for C.I. Pigment Violet 29    

On January 14, 2025, EPA released a proposed risk management rule for C.I. Pigment Violet 29 (PV29), a chemical commonly used in paints, coatings, and plastics. The public comment period was originally scheduled to close on February 28, 2025. However, the agency has now extended the deadline by 60 days, to April 29, 2025. 

The extension is intended to give stakeholders, including industry representatives, environmental groups, and the public, more time to review the proposed regulations and submit their comments. Those interested can provide input through the official docket (EPA-HQ-OPPT-2021-0277) at www.regulations.gov. 

Vinyl Chloride Risk Evaluation Comment Period Extension   

Similarly, EPA has extended the comment period for the draft scope document for the risk evaluation of vinyl chloride, a chemical used primarily in the production of PVC plastics. The draft scope document was initially released with the original comment period set to close on March 3, 2025. The extension grants stakeholders an additional 30 days, extending the deadline to April 2, 2025. 

EPA encourages interested parties to submit feedback on the draft risk evaluation through the docket (EPA-HQ-OPPT-2018-0448) at www.regulations.gov. 

For more details on EPA’s draft decision for C.I pigment violet, see EPA Proposes Rule to Protect Workers from Exposure to C.I. Pigment Violet 29. 

And for vinyl chloride, see our article EPA Classifies Five Substances as High-Priority for Risk Evaluation Under Toxic Substances Control Act. 

The U.S. Environmental Protection Agency (EPA) has extended the public comment period for its draft TSCA risk evaluation for 1,3-butadiene. Originally set to close on February 3, 2025, the deadline is...

The U.S. Environmental Protection Agency (EPA) has extended the public comment period for its draft TSCA risk evaluation for 1,3-butadiene. Originally set to close on February 3, 2025, the deadline is now extended to March 5, 2025, to allow additional time for stakeholders to provide feedback.   

Key Findings of the Draft TSCA Risk Evaluation 

On December 2, 2024, the U.S. EPA released a draft risk evaluation for 1,3-butadiene (CAS No. 106-99-0) under the Toxic Substances Control Act (TSCA) for public comment and peer review by the Science Advisory Committee on Chemicals (SACC). EPA in its risk evaluation determined that 1,3-butadiene poses an unreasonable risk of injury to human health from inhalation exposure to workers and to the general population (including fenceline communities) which is associated with several health effects.   

1,3-Butadiene 

1,3-butadiene is a colorless, highly flammable gas with a mild odor similar to gasoline. It is used primarily in the manufacture of plastics, synthetic rubber (including tires), adhesives, fuels, lubricants, paints, and coatings. The chemical is commonly released into the air during its production and use, with minimal releases to land or water. Beyond industrial exposure, people may also encounter 1,3-butadiene in vehicle exhaust, tobacco smoke, and burning wood. 

Identified Health Risks  

Workers and Occupational Exposure:  

• Workers in manufacturing and processing facilities face significant health risks from inhaling 1,3-butadiene and maintenance and laboratory technicians are particularly vulnerable due to non-routine handling. Health effects include reduced birth weight, blood and immune system diseases, and leukemia. 

Fenceline Communities and the General Population:  

• For people living near industrial facilities long-term exposure from air emissions can lead to serious chronic health effects over time through inhalation. 

Minimal Consumer and Environmental Risk:  

• Consumer exposure is low since only trace amounts of 1,3-butadiene are found in products. The draft evaluation also concludes that there is no unreasonable environmental risk, as 1,3-butadiene does not have a significant impact on land or water. 

Uses of 1,3-Butadiene 

1,3-butadiene uses that pose a significant risk: 

• Manufacturing and processing in industries such as rubber, plastics, adhesives, fuels, and coatings. 

• Handling, repackaging, and disposal of 1,3-butadiene. 

• Recycling and laboratory use. 

Uses that pose low or no risk: 

• Consumer and industrial use in fuels 

• Automotive products 

• Lubricants 

• Packaging 

• Furniture 

• Toys  

• Distribution in commerce 

Public and Peer Review Comments 

EPA was previously accepting public comments for 60 days after the draft evaluation but has extended the comment period from February 3, 2025, to March 5, 2025. Public comments can be submitted to docket EPA-HQ-OPPT-2024-0425 on www.regulations.gov until the new deadline. 

A preparatory public meeting to discuss the scope of the evaluation scheduled for February 4 and the virtual SACC peer review meeting to review public comments and finalize recommendations was scheduled for February 25-28, 2025, but EPA is now rescheduling the February peer review meetings to review additional comments and will announce new dates soon. 

The California Office of Environmental Health Hazard Assessment (OEHHA) has expanded the Proposition 65 listing for Bisphenol S (BPS) to include male reproductive toxicity, effective January 3, 2025. ...

The California Office of Environmental Health Hazard Assessment (OEHHA) has expanded the Proposition 65 listing for Bisphenol S (BPS) to include male reproductive toxicity, effective January 3, 2025.  

BPS Use and Health Concerns 

BPS (CAS No. 80-09-1) is commonly used in plastics, food packaging, and thermal paper receipts, often as a substitute for Bisphenol A (BPA). However, scientific findings suggest that BPS, like BPA, may disrupt hormone function and harm reproductive health. 

The Proposition 65 List 

Proposition 65 requires California to maintain a list of chemicals known to cause cancer, reproductive harm, or both. These chemicals may be present in pesticides, household products, food, drugs, dyes, and solvents, as well as in manufacturing and construction materials. Some are also by-products of chemical processes. 

New Toxicity Endpoint Added 

BPS was first added to the Proposition 65 list on December 29, 2023, due to its effects on female reproductive toxicity. Following a determination by the Developmental and Reproductive Toxicant Identification Committee (DARTIC), acting as the State’s Qualified Experts published on December 12, 2024, the OEHHA expanded the listing to include male reproductive toxicity. 

This update strengthens California’s efforts to protect public health by raising awareness of the potential risks of BPS exposure. From January 3, 2026, businesses are required to provide warnings if their products contain high levels of BPS that could harm male reproductive health.