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The TSCA Backlog: What the Data Tells Us

As of May 28, 2026

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The Backlog at a Glance

Under the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) must review new chemicals before they can enter U.S. commerce.

This page tracks the current performance of EPA’s TSCA new chemicals review program, including the size of the review backlog, how often the agency meets statutory review deadlines and progress being made to reduce the backlog, and what improvements are needed to support American innovation, manufacturing, supply chain resilience, and global competitiveness.

What we Mean by “Backlog”

For purposes of this webpage, the backlog consists of active TSCA Section 5 Premanufacture Notices (PMNs) for which EPA has not made a final statutory determination within the applicable review timeframe – 90 days for PMNs and 30 days for Low Volume Exemptions (LVEs). These represent cases that remain pending at EPA and are not yet able to move forward into U.S. commerce.

Here’s a snapshot of where EPA's TSCA new chemicals program stands:

Of 453 new chemicals currently under EPA review, 416 – nearly 92% – are past the 90-day statutory deadline Congress established in the 2016 Lautenberg TSCA amendments, and 307 have been stalled for more than a year. 

Low-Volume Exemptions (LVEs) cover chemicals produced at 10,000kg per year or less and are reviewed on a 30-day timeline, making them the fastest pathway for specialty and small-batch American chemistry innovations.

This isn't a paperwork problem.
It's a competitiveness problem.

Why This Matters

Under the 2016 amendments to TSCA, EPA has 90 days to determine whether a new chemical can enter U.S. commerce, with extensions not exceeding a total of 90-days allowed for cause. In practice, most reviews take far longer, creating uncertainty for innovators, manufacturers, investors, and downstream users.

Every month a decision is delayed, American innovators wait, U.S. investments stall, and the chemistries that power semiconductors, artificial intelligence, advanced materials, healthcare, energy, and national defense are at greater risk of being developed and manufactured somewhere outside of the United States.

Timely new chemical reviews are essential to America’s ability to build, innovate, compete, and lead. This isn't a paperwork problem. It's a competitiveness problem.

Two Pathways for New Chemicals: PMN vs. LVE

Before a new chemical can enter U.S. commerce, the manufacturer must submit notice to EPA under TSCA Section 5. The review pathway depends primarily on the production volume, intended use, and eligibility of the substance.

How to Think About the Difference

PMNs are the default pathway for new chemicals that do not qualify for an exemption. They are typically used for commodity-scale or full-commercial chemistries that, once cleared, may be added to the TSCA Inventory and manufactured or imported without a low-volume cap.

LVEs provide a limited pathway for eligible chemistries produced in small quantities. The trade-off is straightforward: a binding 10,000 kg-per-year volume cap, specific eligibility criteria, and a shorter 30-day EPA review. LVE substances are not added to the TSCA Inventory in the same way PMN substances are, they are tracked separately and tied to the conditions of the exemption.

PMNs are the front door for commercial-scale chemistry.
LVEs are the front door for specialty innovation.

Both pathways need to function.

A Closer Look: Premanufacture Notices (PMNs)

Premanufacture Notices (PMNs) is the default review pathway under TSCA Section 5(a). Any manufacturer or importer of a new chemical — one not already listed on the TSCA Inventory — must submit a PMN to EPA at least 90 days before commercial production or importation begins.

Statutory AuthorityTSCA Section 5(a); rules at 40 CFR Part 720
Volume CapNone — covers commodity-scale chemistries
Review Timeline90 days, extendable by an additional 90 days for cause (180 days maximum)
Outcome if ClearedThe chemical is added to the public TSCA Inventory and can be manufactured at any volume
EPA DecisionOne of five Section 5 determinations, including "not likely to present an unreasonable risk"

What PMNs Cover

PMNs are the pathway for new chemistries headed for full commercial scale. Unlike LVEs, there is no required production cap, and any restrictions are imposed on a case-by-case basis. Think of the Premanufacture Notice (PMN) process as the front door for commodity chemistry, and Low Volume Exemptions (LVEs) as the front door for specialty innovation. Both need to function and right now, only one is moving.

Typical PMN-route chemistries include:
  • Commodity industrial chemicals: solvents, monomers, and feedstocks produced at industrial scale.
  • Plastics and polymers at scale: new resin grades, engineering plastics, and high-volume polymer building blocks.
  • Coatings, lubricants, and surfactants: commercial-volume formulation chemistries that go into automotive, construction, and consumer products.
  • Intermediates for downstream manufacturing: the building-block chemicals that other U.S. manufacturers depend on to make finished products.
  • New chemistries for energy, agriculture, and water treatment: any large-volume innovation that doesn't qualify for an exemption.

Median PMN Final Determination Review Time*

  • Calendar Year 2025 median: 520 days
  • Calendar Year 2026 Q1 median: 469 days

* Excludes invalid submissions and voluntary withdrawals.

This improvement in early 2026 is meaningful, but median review times remain more than five times longer than the statutory 90-day timeframe and far outside historical norms.

Why the PMN Backlog Hurts

PMNs are where the current backlog lives. Of the 446 active cases, 409, or nearly 91.91%, are past the 90-day statutory deadline. Most are PMNs, and they represent the chemistries that would otherwise be entering U.S. commerce at full commercial volume.

  • Commercial-scale manufacturing stalls. A PMN delay isn't just a paperwork delay. It is a hold on the commodity-volume chemistries that feed downstream U.S. manufacturers, automotive, construction, electronics, packaging, and more.
  • Capital sits idle. Producers commit hundreds of millions of dollars to plants, equipment, and supply contracts on the assumption that EPA will decide on time. Every month a PMN slips, that capital generates no return and investors notice.
  • New chemistries are developed elsewhere. When PMN review becomes unpredictable, multinational producers shift R&D and commercial launches to jurisdictions where the regulatory clock is reliable. When the chemistry production goes overseas, the entire manufacturing value chain goes with it.

PMN is the front door 
for commodity chemistry.

LVE is the front door
for specialty innovation.

Both need to function and right now,
only one is moving.

A Closer Look: Low-Volume Exemptions (LVEs)

LVEs enable eligible new chemistries to enter commerce at small volumes under a streamlined review.

LVEs performed relatively well prior to the 2016 TSCA amendments and again showed stronger performance toward the end of the previous administration. EPA’s recent improvements are welcome, but they have not yet restored the system to historical norms.

Not every new chemical goes through the full 90-day Premanufacture Notice (PMN) process. Under the 2016 TSCA amendments, Congress created a pathway for advanced chemicals produced in small quantities: the Low-Volume Exemption.

Statutory AuthorityTSCA Section 5(h)(4); rules at 40 CFR 723.50
Volume Cap10,000 kg per year or less
Review Timeline30 days (vs. 90 days for a full PMN)
EligibilityAvailable for most new chemicals; PFAS and PBTs are ineligible
Share of CaseloadLVEs and related exemptions are over 50% of annual TSCA Section 5 applications

Median LVE Review Time Trends*

  • LVE median review times rose sharply during 2024, signaling serious process breakdowns.
  • Review times improved significantly during 2025, indicating corrective administrative action.
  • Despite improvement, median LVE review times remain far longer than pre-2016 levels and longer than at the end of the previous decade.

*Excludes invalid submissions and withdrawals.

What LVEs Enable

LVEs are how a great deal of high-value American innovations reaches the market. They are the pathway of choice for chemistries that are produced in small batches but underpin essential industries:

  • Semiconductor manufacturing: photoresists, etchants, and specialty cleaning chemistries used in advanced chip fabrication.
  • Battery and energy-storage materials: electrolyte additives, binders, and cathode and anode components for next-generation EV and grid batteries.
  • Advanced materials and coatings: specialty polymers, adhesives, and surface treatments used in aerospace, defense, and medical devices.
  • Electronics and 3D printing: performance additives, conductive inks, and specialty resins.
  • Specialty chemistries: pharmaceutical intermediates, catalysts, and high-performance functional additives.

Why LVEs Matter

Small volume does not mean small impact. A chemistry produced at a few thousand kilograms per year can be essential to a U.S.-built semiconductor fab, an advanced battery platform, a defense material, or a next-generation medical technology. LVEs are the front door for American chemistry innovation. It is critical to keep that door working is how the U.S. keeps the next generation of advanced manufacturing onshore.

That is why LVE delays carry outsized consequences:
  • Innovation moves at LVE speed. Most genuinely new chemistries enter the market through this pathway. When LVE reviews stall, the entire U.S. specialty chemistry pipeline slows down.
  • Strategic supply chains depend on LVEs. Semiconductors, advanced batteries, and defense materials all run on small-volume specialty inputs. A jammed LVE queue is a national security, reshoring and competitiveness problem, not a paperwork problem.

LVEs are the front door for American chemistry innovation.

Keeping that door working is how the U.S. keeps the next generation of advanced manufacturing onshore.

The 10-Year Submission Trend

TSCA Section 5 annual submissions — the universe of EPA new chemicals reviews — fell sharply after the 2016 TSCA amendments and have not recovered to pre-amendment levels.

The chart shows the trajectory on a federal fiscal-year basis, from Oct. 1 through Sept. 30, consistent with how EPA reports Section 5 program activity.

Three key takeaways:

  • The post-Lautenberg cliff. Submissions dropped significantly between FY2016 and FY2018 as the amended law took effect and uncertainty about review timelines grew. FY2017, the first full fiscal year under the amendments, saw the steepest decline.
  • A flat decade. Submission volumes have increased modestly since FY2018 but remain well below the FY2016 baseline.
  • A modest FY2025 uptick. EPA’s increased LVE clearances in the third quarter of FY2025 and Administrator Lee Zeldin’s stated commitment to clearing the broader backlog appear to have improved confidence at the margin.

Progress Made — and What Is Still Needed

  • EPA leadership and staff have taken meaningful steps to improve new chemical reviews. These efforts matter, and recent median-time improvements show progress is possible.
  • But administrative action alone cannot fix a system whose structure, funding, and accountability mechanisms were not designed for the current workload or statutory expectations.
  • A decade after the 2016 TSCA amendments, U.S. innovators are still filing fewer new chemistries each fiscal year than they were before the law was amended.
  • PMNs are the front door for commodity chemistry. LVEs are the front door for specialty and small batch chemistry innovations. Both need to function and right now, only LVEs are moving.
  • Sustaining and accelerating progress will require durable, structural improvements before EPA’s TSCA fee authority expires on Sept. 30, 2026.

A Roadmap for Timely, Science-Based Reviews

Congress and EPA should work together to:

  • Restore the statutory clock as the norm, not the exception.
  • Anchor reviews in risk, grounded in real-world exposure and intended use.
  • Improve early engagement to avoid unnecessary delays and review resets.
  • Increase transparency through consistent and transparent performance reporting.
  • Fix the funding model, pairing resources with accountability before EPA’s TSCA fee authority expires on September 30, 2026.

The Bottom Line

New chemistries are the building blocks of the next generation of American innovation and manufacturing.

When EPA cannot make timely decisions, the market does not wait. Investment moves. Manufacturing moves. Supply chains move. And the United States risks losing leadership in the industries that will define the 21st century.

Durable TSCA improvements require congressional action.