US TSCA/EPA Chemical Review Backlog: What Importers Should Watch in 2026

What is the current US TSCA/EPA chemical review backlog and why does it matter for importers in 2026?

As of the end of 2023 the EPA reported a backlog of approximately 1,500 chemicals awaiting risk evaluation under the amended Toxic Substances Control Act (TSCA) 1. The agency is required to complete a risk evaluation for each listed substance within a statutory timeframe – typically three years for high‑priority chemicals and five years for low‑priority ones 2. Because the backlog exceeds the annual capacity of EPA’s Office of Chemical Safety and Pollution Prevention, many evaluations are projected to spill into 2026 and beyond.

For importers, the backlog translates into longer waiting periods for pre‑manufacture notices (PMNs) and for decisions on significant new use rules (SNURs). A delayed risk evaluation can also postpone the issuance of a final rule that may impose use‑specific restrictions, affecting supply‑chain planning and compliance budgets.

Which regulatory milestones should importers monitor in 2026 under the TSCA review process?

1. PMN Review Timelines – Under TSCA, any chemical not previously manufactured or imported in the US at a volume of ≥ 25 lb/yr requires a PMN. EPA aims to issue a decision within 90 days, but the current backlog has pushed average processing times to 120–150 days for many high‑volume imports 3.

2. SNUR Publication Dates – When EPA identifies a use of a chemical that may present an unreasonable risk, it publishes a SNUR. Importers must submit a Significant New Use Notice (SNUN) within 90 days of the SNUR’s effective date. In 2026, the EPA expects to publish ≈ 200 SNURs linked to the backlog, up from 140 in 2024 [1].

3. Final Risk Evaluation Reports – The agency’s risk‑evaluation schedule shows that ≈ 350 chemicals slated for completion in 2025 will have their final reports released in early 2026. These reports often contain use‑specific restrictions that can affect imported intermediates.

4. TSCA Amendments and Guidance Updates – The EPA periodically issues guidance on data requirements for PMNs and SNUNs. The most recent guidance (June 2024) emphasises electronic submission of analytical data (e.g., HPLC, GC‑MS) and encourages alignment with REACH dossiers 4.

Staying abreast of these milestones via the EPA’s TSCA docket (https://www.regulations.gov) and the Federal Register is essential for proactive risk management.

How can importers prepare documentation to mitigate delays caused by the TSCA backlog?

| Action | Recommended Content | Benefit | |--------|--------------------|---------| | Comprehensive PMN Dossier | Full chemical identity (CAS #, structure), manufacturing volume, exposure scenarios, and existing safety data (e.g., NMR, HPLC purity, toxicology studies). Include a CoA and an up‑to‑date SDS. | Reduces EPA queries; shortens the 90‑day review window. | | Pre‑emptive SNUN Submission | If a planned use could fall under a likely SNUR, submit a SNUN with mitigation measures (e.g., engineering controls, PPE) before the SNUR is finalised. | Avoids mandatory shutdowns and costly post‑SNUR compliance. | | REACH‑Aligned Dossiers | Mirror the structure of REACH registration dossiers – chemical safety report, exposure assessment, and downstream use information. This eases data exchange if EPA requests additional information. | Streamlines cross‑jurisdictional compliance and leverages existing data. | | Electronic Data Packages | Use EPA’s TSCA Submission Portal to upload raw analytical data (e.g., GC‑MS spectra) in the required formats. Ensure files are labelled with version control. | Facilitates rapid EPA review and reduces the need for follow‑up requests. | | Supply‑Chain Transparency | Maintain a register of all downstream users and their intended applications, with contact details for rapid communication. | Enables swift response to EPA’s use‑specific queries. |

Molekula’s technical support team can assist in formatting CoAs and SDSs to meet EPA’s electronic standards, but the primary responsibility for dossier completeness rests with the importer.

What are the implications of SNURs and PMNs for imported chemicals in 2026?

• SNUR Enforcement – Failure to submit a SNUN within the 90‑day window can result in civil penalties up to $37,500 per day per violation (adjusted for inflation) 5. EPA may also issue a stop‑sale order, halting imports until compliance is demonstrated.
• PMN Data Gaps – EPA may request additional toxicological data if the initial PMN lacks sufficient information to assess risk. In 2024, ≈ 22 % of PMNs required supplemental data; the proportion is expected to rise as the backlog persists [3].
• Trade‑off with REACH – Companies that have already completed REACH registration for a substance often possess the required toxicology data, allowing faster PMN approval. However, EPA still requires US‑specific exposure scenarios, so a direct data transfer is not sufficient.
• Strategic Import Planning – Importers should consider staggered shipments, alternative suppliers, or temporary substitution for chemicals likely to be targeted by SNURs. Early engagement with EPA through the TSCA Hotline can provide informal guidance on high‑risk substances.

By anticipating SNURs, maintaining complete PMN dossiers, and leveraging REACH‑compatible data, importers can reduce the risk of costly delays and regulatory enforcement actions in 2026.

Sources

1. TSCA Chemical Review Backlog – U.S. Environmental Protection Agency
2. TSCA Risk Evaluation Process – U.S. EPA
3. TSCA: Overview and Recent Developments – Congressional Research Service
4. REACH – Registration, Evaluation, Authorisation and Restriction of Chemicals – European Chemicals Agency
5. TSCA Import Requirements – U.S. Customs and Border Protection