USA Regulatory News

On June 13, 2025, the U.S. Environmental Protection Agency (EPA) issued a final rule in the Federal Register (90 FR 24977), establishing Significant New Use Rules (SNURs) under the Toxic Substances Co...

On June 13, 2025, the U.S. Environmental Protection Agency (EPA) issued a final rule in the Federal Register (90 FR 24977), establishing Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA). The rule applies to specific chemical substances that were previously submitted through Premanufacture Notices (PMNs) and are also subject to EPA Orders under TSCA. 

Mandatory Notification for New uses 

The rule requires any individual or company intending to manufacture (including import) or process these substances for a “significant new use” to notify EPA at least 90 days in advance. This notification allows EPA to assess potential risks and determine if restrictions are needed before the activity begins. 

Effective and Promulgation Dates 

 The rule will take effect on August 12, 2025. For judicial review purposes, the rule will be officially promulgated at 1 p.m. EST on June 27, 2025. 

Codification and Compliance 

These SNURs are codified under Title 40 CFR Parts 9 and 721. The affected substances are already subject to risk management provisions in TSCA orders, including exposure control and hazard communication measures. The SNURs ensure that any new or expanded uses beyond these existing terms are properly reviewed by EPA. 

Access to Supporting Documents 

Supporting documents and the full rule are available in Docket EPA-HQ-OPPT-2023-0328 on Regulations.gov, and the rule was notified internationally under WTO symbol G/TBT/N/USA/2125/Add.1.

On June 23, 2025, the U.S. Environmental Protection Agency (EPA) announced a 60-day extension of the postponement of specific regulatory provisions from its final rule on trichloroethylene (TCE) under...

On June 23, 2025, the U.S. Environmental Protection Agency (EPA) announced a 60-day extension of the postponement of specific regulatory provisions from its final rule on trichloroethylene (TCE) under the Toxic Substances Control Act (TSCA). The extension applies to conditions affecting uses of TCE which are covered by TSCA Section 6(g) exemptions. 

Additional Time for Compliance and Feedback 

The original rule, published on December 17, 2024 (89 FR 102568), included new requirements for how TCE can be used, even in cases where exemptions apply. These requirements were already postponed once, and as of June 20, 2025, EPA has further delayed their start date to August 19, 2025. 

This extension allow EPA to consider implementation issues and review any concerns raised by stakeholders. It also gives affected businesses more time to prepare for compliance. 

Comment Opportunities 

Anyone interested can view the related documents and submit comments by searching for Docket Number EPA-HQ-OPPT-2020-0642 on Regulations.gov. or can click on the link provided here. 

This action is part of EPA’s broader goal of managing chemical risks effectively while also ensuring that exemptions under TSCA are handled with regulatory clarity and sufficient transition periods for compliance. 

On June 23, 2025, the U.S. Environmental Protection Agency (EPA) published a final rule issuing Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical sub...

On June 23, 2025, the U.S. Environmental Protection Agency (EPA) published a final rule issuing Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were previously submitted as Premanufacture Notices (PMNs) and subject to TSCA Orders. 

90-Day Advance Notification Required 

The rule requires manufacturers and processors to notify EPA at least 90 days prior to engaging in any activity deemed a significant new use. This advance notification allows EPA to assess and, if necessary, regulate the associated risks before the activity begins. 

The rule will take effect on August 22, 2025, and is scheduled to be officially announced in the Federal Register on July 7, 2025. The final rule is available in the Federal Register (90 FR 26437).  Relevant documents can also be accessed via Regulations.gov by searching the docket number (EPA-HQ-OPPT-2024-0077).  

In June 2025, the U.S. Environmental Protection Agency (EPA) released its draft risk evaluation for dibutyl phthalate (DBP), also known as 1,2-benzenedicarboxylic acid, 1,2-dibutyl ester (CAS No. 84-7...

In June 2025, the U.S. Environmental Protection Agency (EPA) released its draft risk evaluation for dibutyl phthalate (DBP), also known as 1,2-benzenedicarboxylic acid, 1,2-dibutyl ester (CAS No. 84-74-2) under the Toxic Substances Control Act (TSCA). The draft, and its technical support documents, are now open for a 60-day public comment period and scheduled for peer review by the Science Advisory Committee on Chemicals (SACC) from August 4–8, 2025. 

EPA designated DBP as a High-Priority Substance in December 2019 due to potential risks to human health and the environment. The draft evaluation is part of the agency’s ongoing review process under TSCA to determine whether existing chemicals present an unreasonable risk under current conditions of use (COUs). 

Key Findings from the Draft Risk Evaluation   

EPA’s preliminary determination concludes that DBP presents an unreasonable risk of injury to human health from 20 worker-related COUs, 4 consumer COUs, and one environmental COU. These findings are based on exposure scenarios that do not account for the use of personal protective equipment (PPE). However, the report notes that PPE could potentially reduce exposure and mitigate risks. 

Importantly, the agency did not identify unreasonable risks to the general population or from cumulative exposure across conditions of use. Additionally, no unreasonable risk was found for the 19 other COUs considered in the evaluation. 

Background and Use of DBP   

DBP is a colorless to pale yellow oily liquid, primarily used as a plasticizer in adhesives, sealants, paints, and coatings. Data from EPA’s 2016 Chemical Data Reporting indicates that U.S. production and import volumes of DBP range from 1 million to 10 million pounds per year. 

EPA's risk evaluation considers various COUs, including: 

• Use in adhesives and sealants 

• Paints and coatings 

• Laboratory chemicals 

• Commercial and consumer products such as floor coverings, furniture, lubricants, and light sticks 

Public Involvement   

Stakeholders can submit comments on the draft risk evaluation through docket EPA-HQ-OPPT-2018-0503 at regulations.gov. EPA encourages active participation from industry, environmental groups, and the public to inform its final risk determinations. 

Further engagement is expected as EPA finalizes the evaluation to ensure transparency and scientific rigor in the chemical safety process under TSCA.

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.