USA Regulatory News

The U.S. Environmental Protection Agency (EPA) is inviting nominations of qualified scientists to serve as ad hoc peer reviewers for the draft risk evaluation of octamethylcyclotetrasiloxane (D4, CAS...

The U.S. Environmental Protection Agency (EPA) has issued Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were subjected to Premanu...

The U.S. Environmental Protection Agency (EPA) has released draft risk evaluations for two widely used chemicals under the Toxic Substances Control Act (TSCA) :Butyl Benzyl Phthalate (BBP, CASRN 85-68...

The U.S. Environmental Protection Agency (EPA) has released draft risk evaluations for two widely used chemicals under the Toxic Substances Control Act (TSCA) :

• Butyl Benzyl Phthalate (BBP, CASRN 85-68-7)
• Diisobutyl Phthalate (DIBP, CASRN 84-69-5)

These evaluations form part of EPA’s ongoing efforts to protect human health, consumer safety, and the environment by ensuring potentially harmful chemicals are properly assessed and regulated. Stakeholders are encouraged to participate in the process by reviewing the draft evaluations and submitting comments before the deadline.

Key Findings

EPA’s draft evaluations, prepared using the best available science, preliminarily conclude that both BBP and DIBP pose unreasonable risks to health and the environment under certain conditions of use.

• Risks extend to potentially exposed or susceptible groups, such as workers or children.
• Economic or other non-risk factors were not considered in accordance with TSCA.

Publication and Comment Details

The notice was published in the Federal Register on 6 August 2025 (90 FR 37855, Doc. No. 2025-14882).

Dockets:

• EPA-HQ-OPPT-2018-0501 (BBP)
• EPA-HQ-OPPT-2018-0434 (DIBP)

Comment Deadline: 6 October 2025, 4:00 PM EST

Submit via: USA WTO TBT Enquiry Point Email: usatbtep@nist.gov

Next Steps

EPA will review all comments received and finalize the risk evaluations. If the final assessments confirm unreasonable risk, the Agency will proceed to risk management actions under TSCA §6(a) to reduce or eliminate those risks.

On 21 July 2025, the U.S. Environmental Protection Agency (EPA) announced the addition of 18 chemicals to the Safer Chemical Ingredients List (SCIL), advancing Administrator Zeldin’s commitment to t...

On 21 July 2025, the U.S. Environmental Protection Agency (EPA) announced the addition of 18 chemicals to the Safer Chemical Ingredients List (SCIL), advancing Administrator Zeldin’s commitment to transparency, innovation, and safer chemistry.

Under the Toxic Substances Control Act (TSCA), new chemicals cannot enter the U.S. market without EPA approvement. This can slow the introduction of innovative chemistries and result in older substances remaining in use longer. Expanding SCIL helps address this by identifying existing chemicals that meet Safer Choice criteria, offering manufacturers and consumers clearer access to safer alternatives.

SCIL Additions Offer Safer Alternatives

Adding existing chemicals to the Safer Chemical Ingredients List (SCIL) supports consumers, businesses, and buyers in choosing chemicals that are among the safest for their intended uses. It also helps manufacturers identify safer substitutions that meet the Safer Choice program’s criteria

Newly Added Chemicals to SCIL

For additional background and information about a previous update and more information on Safer Chemical Ingredients List (SCIL), please refer to the EPA Updates Safer Chemical Ingredients List with Addition of 27 New Chemicals.

On July 17, 2025, the U.S. Environmental Protection Agency (EPA) published a final rule in the Federal Register (90 FR 33283), establishing Significant New Use Rules (SNURs) under Toxic Substances Con...

On July 17, 2025, the U.S. Environmental Protection Agency (EPA) published a final rule in the Federal Register (90 FR 33283), establishing Significant New Use Rules (SNURs) under Toxic Substances Control Act (TSCA). These rules apply to several chemical substances previously reviewed through premanufacture notices (PMNs) and also subject to TSCA Orders issued by EPA.

New Use Notification Requirement 
Under the SNURs, any person intending to manufacture (including import) or process the listed chemical substances for a use designated “significant new use” must submit a Significant New Use Notice (SNUN) to EPA at least 90 days in advance. This notification initiates EPA's evaluation of the intended use and ensures that manufacturing or processing cannot begin until EPA has completed its review and taken any required actions.

Effective and Promulgation Dates 
Final rule is codified under 40 CFR Part 721 and becomes effective on September 15, 2025.

Access to Rule Documents 
The final rule and supporting documents are available in Docket EPA-HQ-OPPT-2024-0079 on Regulations.gov. The measure was previously notified to the World Trade Organization under the symbol G/TBT/N/USA/2171 and the final text is provided through Addendum 1.

EPA encourages stakeholders to review the final rule carefully to ensure full compliance with the SNUR notification requirements before undertaking any new use of the listed substances.

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.