The Significant New Use Notice Trap: Why Procurement, Not Compliance, Files Most SNUNs Late
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The Significant New Use Notice Trap: Why Procurement, Not Compliance, Files Most SNUNs Late

EPA requires a Significant New Use Notice 90 days before a SNUR-listed chemical hits a new application. Three SNUR batches take effect July 2026, and the penalty for a missed filing is $49,772 per day. Most filings are late because the trigger lives in procurement, not annual compliance review.

by iSi Environmental

The plant manager did not know the feedstock had been switched. The procurement lead did. The procurement lead did not know the substitute was on a Significant New Use Rule list, because the rule masked the chemical identity as Confidential Business Information. By the time the EHS director ran the annual TSCA screen, the new use had been running for four months. At up to $49,772 per day per violation (40 CFR 19.4 Table 1), the per-day clock had already produced a seven-figure exposure inside a workflow that nobody thought was a compliance workflow.

Updated June 11, 2026: added the July 2026 SNUR batch effective dates, corrected the per-day penalty figure against the current eCFR table, and added the Fifth Circuit’s Inhance ruling on what counts as a “new” use.

That is the structural reason most Significant New Use Notice (SNUN) filings under the Toxic Substances Control Act arrive late. The 90-day pre-notification clock is not the problem. The problem is that the clock starts at the procurement bench or the R&D scale-up, not at the regulatory affairs desk where the calendar lives. This post walks through the actual filing mechanics — fee structure, the R&D exemption, joint-filer rules, EPA’s review backlog — and where the operational failure points sit for mid-sized manufacturers. It is the operational counterpart to our April analysis of the SNUR-26-2 batch rule, which covered what the rule contains. This post covers what you actually file when you get hit by one.

What Triggers a SNUN Obligation Under TSCA Section 5

Under TSCA Section 5(a)(2), once EPA promulgates a Significant New Use Rule for a chemical, any person who manufactures, imports, or processes that chemical for the designated significant new use must submit a Significant New Use Notice at least 90 days before commencing that use. The implementing regulations sit at 40 CFR Part 721, with the submission mechanics at 40 CFR 721.25. The filing goes through EPA’s e-PMN electronic submission system on the same form used for Pre-Manufacture Notices, with a cover letter identifying the CFR citation of the triggering SNUR and the specific significant new use being addressed (EPA — Filing a SNUN).

The first practitioner mistake is treating SNUN coverage as a chemical-manufacturer obligation. It is not. The trigger covers:

  • Chemical manufacturers producing the substance for the designated new use
  • Importers bringing the substance across the U.S. border for the designated new use (manufacture under TSCA includes import)
  • Processors receiving a SNUR-listed chemical for a designated new use — formulators, blenders, coating operations
  • Downstream users in sectors named in the rule (automotive coatings, lithium battery production, textile manufacturing, semiconductor cleanrooms)
  • R&D and contract manufacturers scaling up compounds for new applications

If a substance is on the list and your operation touches the designated new use, you have a filing obligation. EPA built joint-SNUN authority into 40 CFR 721.25(b) specifically because real supply chains involve multiple actors hitting the same trigger.

How Much Does a SNUN Filing Cost?

EPA’s SNUN fee structure has two tiers tied to business size under 13 CFR 121.201 size standards:

  • Small business: $3,300 per filing
  • Large business: $19,020 per filing

Joint SNUNs under 40 CFR 721.25(b) split the fee across filers. For a processor-importer pair that coordinates the filing before the new use begins, the $19,020 large-business fee can split into a fraction of that for each party. Few practitioners use this mechanism, mostly because coordination has to happen before the trigger event — once the new use commences, the parties collapse back into separate full-fee filings (EPA — Filing a SNUN).

The fee is not the issue. The cost asymmetry is. A single missed SNUN screen on a switched feedstock creates per-day liability at up to $49,772 per violation per day under 15 U.S.C. § 2615(a)(1), as set in 40 CFR 19.4 Table 1 (effective for penalties assessed on or after January 8, 2025). At 60 days of unauthorized manufacture, the exposure is approximately $2.99 million before any penalty mitigation — that is the mathematical floor, not a worst case. The 2025 inflation-adjusted penalty level carries into 2026 with no further adjustment — OMB’s April 17, 2026 guidance directed agencies to continue using 2025 amounts because the October 2025 CPI-U was not released during the federal appropriations lapse.

What Changed in June: Three July Effective Dates

Four SNUR batches moved in the six weeks after this post first published — an active rulemaking pace that does not suggest a slowdown in SNUR activity even amid the broader deregulatory environment:

  • Batch 25-1.5e — final rule published May 22, 2026. Effective July 21, 2026. Covers PMN-reviewed substances subject to TSCA Section 5(e) consent orders.
  • Batch 25-2.5e — final rule published May 29, 2026. Effective July 28, 2026. Same mechanics, different chemical cohort (91 FR, 2026-10712).
  • Batch 25-3.5e — proposed June 5, 2026; comments due July 6, 2026 (2026-11319).
  • Batch 26-2 — comment period extended to July 10, 2026 (2026-10161).

If your operation uses chemicals recently subject to Section 5(e) consent orders, those are the substances the two final-rule batches target. For genuinely new uses approaching the July 21 or July 28 effective dates, the 90-day clock should already be running — if it is not, that conversation needs to happen this week.

When a Use Is Not “New”: The Inhance Boundary

One court decision is quietly narrowing what “new use” means. In Inhance Technologies v. USEPA (5th Cir., No. 23-60620), the Fifth Circuit held that a 40-year-old fluorination process could not be characterized as a “significant new use” simply because EPA recently discovered PFAS byproducts from it. The court’s reasoning: Section 5’s new-chemical review authority covers what is actually new; for established processes EPA wants to restrict, the agency has Section 6 risk management tools — which carry heavier procedural burdens.

The boundary matters more than the headline. The Inhance argument applies to established industrial practices conducted continuously before a SNUR’s effective date. If your operation is changing feedstocks, scaling R&D into commercial production, entering a new application market, or adding a processing step — those are new uses, and Inhance does not protect you. For long-established processes touched by a new SNUR, document why the use is not “new” under the Inhance standard before relying on it.

Why the R&D Exemption Fails Under Inspection

40 CFR 721.47 carves out small-quantity research from SNUN obligations, conditional on meeting the R&D recordkeeping and worker-notification requirements at 40 CFR 720.36. The exemption is real. The way most manufacturers claim it is not defensible.

The structural problem: “small quantities” is not quantitatively defined. EPA deliberately left it open, using the practitioner test “not greater than reasonably necessary” for the research purpose (40 CFR 720.3(cc)). That means the burden of the analysis sits with the manufacturer, not the regulator. If EPA inspects and the manufacturer has no contemporaneous documentation of:

  1. The research purpose
  2. The volume actually used
  3. Why that volume was the minimum reasonably necessary
  4. Worker notification records
  5. Containment and disposal procedures

— the exemption claim fails. The exposure then resets to the per-day clock from the date the new use began. Undocumented R&D exemption claims do not survive inspection. The defense is a file, built before the scale-up, that shows the screen happened and the conclusion was defensible.

What Does the EPA Backlog Actually Mean for the 90-Day Clock?

This is the counter-signal practitioners need to internalize. The 90-day pre-notification window is a regulatory floor, not an operational ceiling.

EPA’s published submission status data shows 421 pending PMN/SNUN/MCAN filings as of May 1, 2025, and 127 of 142 filings from the May 2024–May 2025 cohort were still undecided (EPA — PMN/SNUN Submissions). The Office of Chemical Safety and Pollution Prevention is in the process of redirecting roughly 130 scientists, bioinformaticians, and IT specialists toward new-chemical evaluations to ease the backlog, but the structural pattern remains: 90-day extension notices, consent order negotiations, and additional-data requests routinely stretch the actual hold period into 6–12 months for non-priority chemistries, and longer for mixtures, polymers, and substances with limited toxicity data.

Two operational consequences:

The SNUN filer cannot start the new use until EPA acts or the statutory clock expires uninterrupted. Manufacturers planning a feedstock change, an end-use expansion, or an R&D scale-up should budget the full backlog window into project timelines, not 90 days. Procurement and operations need to know that “we filed the SNUN” does not mean “we can start in 90 days.” It means “the clock is paused until EPA finishes review or the statute runs.”

Project schedules built on a 90-day assumption produce two failure modes. Either the new use starts anyway (creating the per-day violation the SNUN was supposed to prevent), or the line sits idle while EPA’s queue moves — and the cost of an idle production line waiting on a regulatory decision is its own seven-figure problem.

The CBI Screening Problem

This is the operational wrinkle nobody talks about. SNURs frequently mask chemical identity as Confidential Business Information, which means the regulatory text identifies a substance class and a designated new use but not the specific chemical name. A plant manager cannot run a simple keyword search against the raw material list and confirm a hit. The screen has to go through EPA’s bona fide intent-to-manufacture procedures or rely on supplier attestation that the substance in a tank is or is not the masked CBI substance in the SNUR.

What this means in practice: every procurement change involving a new chemical, a new supplier, or a new application needs a CBI-aware screening step. Suppliers should be asked in writing whether the substance they are supplying is subject to any active SNUR under 40 CFR Part 721, including SNURs that mask the substance as CBI. A “we don’t know” answer is not a defense — the obligation runs to the manufacturer, importer, or processor performing the new use, not to the supplier.

Where Enforcement Is Actually Going in 2026

In January 2026, EPA amended the TSCA Section 5 Enforcement Response Policy specifically to cap penalties for failure to submit timely Notices of Commencement (NOCs). Practitioners should not over-read this as a softening of TSCA enforcement. It is a narrow procedural concession that procedural TSCA-5 violations had become punitively over-weighted. The substantive SNUN obligation was not relaxed. The per-day penalty structure under 15 U.S.C. § 2615(a)(1) remains intact at the 2025 inflation-adjusted level.

The enforcement perimeter is shifting. In December 2025, EPA announced an expansion of its imports investigative capacity, targeting illegal pesticide and chemical smuggling (EPA — Actions under TSCA Section 5). The operational read: import-channel TSCA enforcement is the active priority right now. Chemical importers and downstream users receiving imported feedstocks face the highest enforcement exposure under current EPA posture, not domestic-only manufacturers. If your supply chain runs through an imported feedstock, your SNUN exposure is the live one.

For the iSi service region — Kansas, Oklahoma, Texas, Missouri, Nebraska — no material state-level SNUN overlay exists. TSCA is federally preemptive for new-chemical review under Section 18. State chemical reporting programs like Massachusetts TURA or California Proposition 65 operate in parallel but do not substitute for or modify the federal SNUN obligation. The federal standard is the standard.

The Compliance Workflow Most Manufacturers Need to Build

The reason SNUN violations originate at procurement and R&D is that those workflows operate on different time signatures than annual compliance review. A procurement decision to switch a feedstock for cost or supply reasons can move from “let’s evaluate” to “let’s place the order” in two weeks. The annual TSCA screen runs in Q4 or Q1, after the order has shipped. By the time the screen catches the new use, the per-day clock has been running for six months.

The fix is structural. SNUR screening belongs embedded in three workflows:

  1. Procurement change control. Every new supplier, every new substance, every change in supplier specification triggers a SNUR screen. Procurement asks the question; EHS or regulatory affairs answers it.
  2. R&D-to-commercial scale-up gates. Before any compound moves from bench to pilot to commercial, the SNUR screen runs and the R&D exemption documentation gets filed (if applicable) or the SNUN filing timeline gets booked.
  3. Process change management. Any change in end-use, exposure pathway, worker population, or production volume gets screened against the active SNURs at 40 CFR Part 721 Subpart E.

This is the same systematic approach that prevents OSHA, EPA, and state-agency violations from showing up at the worst possible time. The screening question is cheap. The undocumented new use is not. That is the cost asymmetry that should drive the workflow design.

What a Defensible SNUN File Looks Like

When the SNUN is required, the file EPA expects to see — and the file an inspector will reconstruct after the fact if the SNUN is missing — includes:

  • The screening record showing the substance was identified as SNUR-listed (with the 40 CFR Part 721 Subpart E citation)
  • The use-mapping analysis showing how the operation’s actual use compares to the designated significant new use in the rule
  • The R&D exemption analysis if exemption is claimed (volume, purpose, “not greater than reasonably necessary” justification)
  • The SNUN cover letter identifying the CFR citation of the triggering SNUR and the specific significant new use being addressed
  • The e-PMN submission record and EPA acknowledgment
  • The fee payment record (small or large business, joint filing if applicable)
  • The hold record showing the new use did not commence until EPA’s 90-day review period closed uninterrupted, or until EPA’s review concluded

For SNUR-26-2 specifically — comment period now extended to July 10, 2026 — SNUNs for in-flight new uses will be due 90 days after the eventual effective date (SNUR 26-2 Federal Register publication). Manufacturers running any of the substances on that list for any of the designated new uses should already be building the file. The nearer deadlines are Batches 25-1.5e and 25-2.5e, effective July 21 and July 28 — see the What Changed in June section above.

The Practitioner Takeaway

The 90-day SNUN clock is one number. The operational reality is three numbers running on different timelines: the procurement decision (weeks), the SNUN filing window (90 days statutory minimum), and the EPA review backlog (6–12+ months in practice). If your compliance system only tracks the 90-day number, the other two will produce violations the system never sees coming.

The fix is upstream. SNUR screening lives in procurement change control and R&D scale-up gates, not in annual compliance review. The screening question takes minutes. The documented file takes hours. The per-day penalty clock on an undocumented new use takes a single missed feedstock switch and runs until someone notices.

For manufacturers running mid-sized operations where the regulatory affairs function is one person — or part of one person’s job — embedding the SNUR screen into procurement and process-change workflows is exactly the kind of structural work iSi’s EHS COOP retainer handles inside an operation. We integrate as augmentation for your team: when your procurement lead sends the spec for a new feedstock, the SNUR screen runs against the active 40 CFR Part 721 Subpart E list before the order goes out. We were waiting at the door before EPA opened it, because that is what the retainer is for.

If a feedstock change is in flight at your facility right now and the SNUR screen has not been documented, that is the call to make today.

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