EPA Issues Significant New Use Rules for TSCA

The EPA is issuing a set of Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA). In this blog we will provide all the information your business needs to understand the new legislation and make sure your products remain compliant.   

What is TSCA and Who Does It Apply To?

The Toxic Substances Control Act (TSCA) is the primary U.S. law regulating the manufacture, import, processing, distribution, and use of chemical substances to protect human health and the environment from unreasonable risks.

Administered by the Environmental Protection Agency (EPA), TSCA applies broadly across industries that produce or use chemicals, including chemical manufacturing, electronics, automotive, aerospace, consumer goods, petroleum refining, textiles, and more. Companies in these sectors must ensure compliance when introducing new substances, engaging in significant new uses of existing chemicals, or managing substances already subject to restrictions, making TSCA a critical framework for both regulatory oversight and corporate responsibility.

What’s the Rule About

These SNURs apply to certain chemical substances which have already been reviewed under premanufacture notices (PMNs) or Microbial Commercial Activity Notices (MCANs), and are further regulated under TSCA Orders. 

The point is to ensure that if anyone wants to engage in a use of those chemicals that is “new” or outside the scope of previously permitted/ongoing uses (or is otherwise restricted under the TSCA Orders), they must notify and get EPA’s review before doing so. This gives EPA ability to assess risks in advance and impose necessary safety / exposure controls. 

Key Dates & Applicability

• Effective date: September 29, 2025.

• Judicial review date: August 12, 2025 (for certain legal purposes).

• The rule is final — meaning what was proposed in August 2024 has been adjusted/responded to, and changes incorporated.

Who’s Affected

• Anyone who manufactures, imports, processes, or uses the chemical substances listed in the rule, if doing so in a way that is designated a “significant new use.”

• Also importers/exporters must follow associated import/export requirements under TSCA (e.g. export notifications).

• Industries under chemical manufacturing (NAICS code 325), petroleum refineries (NAICS 324110) are explicitly mentioned examples.

If you already are using one of the listed chemicals in a manner compliant with existing TSCA Orders, you may be okay. But any deviation or new use may trigger obligations. 

What Obligations are Imposed

• 90-day advance notice: Before commencing a significant new use, you must submit a Significant New Use Notice (SNUN) to EPA. The notification triggers EPA’s review.

• No commencement of the new activity until EPA has reviewed and acted.

• Hazard communication, workplace protection, and other controls may be required. Specific requirements vary by substance and use.

• Recordkeeping requirements and monitoring for import/export/export notifications where applicable

Specific Changes from the Proposal

The final rule incorporated a number of adjustments in response to public comments. A few examples:

• For some PMNs (e.g. P-20-175, P-20-176, P-20-178), EPA removed proposed “release to water” requirements due to data showing low environmental hazard. Also adjusted hazard communication requirements. 

• For others, EPA added or modified concentration thresholds (“de minimis” provisions) such as 1.0% or 0.1% according to the underlying TSCA Orders. 

• Clarifications on import manner (e.g., whether imported in solution or container size) for certain substances.

Economic & Compliance Impacts

• SNUN submission cost estimates: $45,000 for large businesses, $14,500 for small businesses.

• User fees: For large entities, $37,000. For qualifying small businesses the fee is reduced to $6,480..

• The export notification cost per notification is modest (estimated US$106). However the total depends on how many countries your exports go to

• The regulatory burden (time, paperwork, data) is estimated at 30-170 hours per SNUN.

The EPA has certified that the rule will not have a significant economic impact on a substantial number of small entities. 

What You Should Do

If this rule might affect you, here are actions to consider:

1. Check if any of your substances are covered: review the list of PMNs / substances and whether your current or planned uses align with what the rule considers “ongoing” vs “significant new use.”

2. Review TSCA Orders for each such substance: determine what restrictions are already in place (uses, exposures, communications, import/export) and see whether your planned activity is outside those restrictions.

3. If planning a new use (change in processing, concentration, route of exposure, import mode, etc.), plan for a SNUN: collect data early, understand reporting and testing obligations. EPA encourages early communications especially for testing protocols and consider alternative, non-vertebrate test methods.

4. Update internal compliance / safety / supply chain practices: hazard communication, workplace protection, recordkeeping, import/export certification may need updating.

5. Budget and timeline: because of fees, review periods, possible delays, ensure you allow enough lead time if you intend to start something that may be a significant new use after Sept 29, 2025.

Why This Matters

• The rule strengthens oversight over substances whose risks may change depending on how they are used. New uses may involve exposures that weren't assessed before.

• It helps to prevent “unknown risk” scenarios— where a previously limited chemical suddenly gets used in broader applications without risk mitigation.

• From a business perspective, noncompliance could lead to enforcement action, production/import delays, or cost penalties.

How GoCompliance Can Help

GoCompliance helps companies simplify and stay ahead of their TSCA compliance obligations by automating data collection, tracking, and reporting across the supply chain. 

Instead of manually managing supplier questionnaires, safety data sheets, and regulatory updates, GoCompliance centralizes everything in one platform, all while integrating directly with Oracle Cloud PLM or your existing ERP/PLM systems. Our AI-powered agents validate supplier declarations, monitor for regulatory changes, and generate audit-ready documentation, ensuring you can quickly identify whether a substance or product is impacted by TSCA requirements. 

This not only reduces compliance risks and costly delays but also gives your teams confidence that every chemical, component, and finished good meets EPA standards before reaching the market.

Find out how our platform can take the burden out of compliance by booking your personalized walkthrough today.