Compliance

EPA Wants to Rewrite TSCA Risk Evaluations. What the Proposed September 2025 Rule Changes Mean for US Chemical Importers Who Source from China

10 min read Sourzi Editorial
TSCA Compliance Risk Evaluation EPA Enforcement PMN Requirements

The Environmental Protection Agency published proposed amendments to the TSCA Section 6 Risk Evaluation Framework Rule in September, and the comment docket closed on 7 November. If you import industrial chemicals from China into the US, this proposal is not procedural housekeeping. It is a structural rewrite of how EPA decides whether a chemical you have been shipping for fifteen years is suddenly “unreasonable risk” and therefore a candidate for use restriction, labelling mandates or outright ban.

The shift is from chemical-wide evaluations to use-specific evaluations. On paper, that sounds like a targeting improvement. In practice, it means EPA can slice one chemical across ten or twenty “conditions of use” and restrict some while letting others through, and importers have to prove which use bucket their shipments sit in every time a CBP officer pulls a container for inspection.

 Aerial view of chemical tanker ship at sea with cargo containers visible, illustrating international chemical trade routes

Since January 2025, EPA has pursued 115 TSCA enforcement actions and assessed roughly $4.3 million in penalties. That is 115 import shipments, Premanufacture Notice filings or distribution decisions that regulators decided were out of compliance, many of them involving chemicals of Chinese origin. The proposed rule is going to make the compliance envelope narrower, not wider, and your 2026 import programme needs to be built around the new framework even while the comment docket is still being digested.

What the Proposed Rule Actually Changes

The existing Framework Rule, finalised in 2017 and amended in 2024, required EPA to evaluate a chemical across its full range of conditions of use in a single risk evaluation. Under the proposal, EPA would have flexibility to define narrower evaluation boundaries, potentially evaluating only specific uses of concern and leaving others for later or separate proceedings.

For a US importer sourcing a solvent, surfactant or intermediate from a Wanhua or Sinopec plant in China, the practical effect is threefold. First, a chemical currently labelled “Pass” under the 2017 framework for your industrial use could be revisited under the new use-specific framework and reclassified. Second, PMN workloads go up because each new use of an existing chemical may need a separate filing rather than sitting under a broad existing-chemical authorisation. Third, enforcement risk jumps because the “which use” determination shifts from EPA’s risk evaluation to the importer’s declaration on arrival.

EPA also proposed changes to how occupational exposure is weighted, how consumer use scenarios are modelled, and how “reasonably available information” is defined for data-gap-filling. Each of those is a lever that, used aggressively, can turn a chemical from an approved import into a restricted one. The agency has signalled that the methylene chloride, perchloroethylene and 1-bromopropane rulings are the template, which means bans or severe use restrictions are on the table for any chemical that ends up on the priority list.

The 115 Enforcement Actions Tell You What EPA Cares About

EPA has been building the enforcement case over the same period it has been drafting the rule. The 115 actions since January 2025 break down across a predictable set of failure modes, and if your import programme has any of these gaps, you are on the target list.

Enforcement CategoryTypical Fact PatternPenalty RangeAction for Importers
PMN failureNew chemical imported without a PMN filed 90 days in advance$37,500 to $500,000 per shipmentAudit every substance against TSCA Inventory
Significant New Use Rule violationExisting chemical imported for a use covered by a SNUR without notice$37,500 per day of violationCross-check SNUR list against product uses
Import Certification errorSection 13 certification missing or inaccurate on entry$37,500 per entryTemplate correction with broker
Chemical Data Reporting lapseManufacturers and importers missed 2024 CDR cycleUp to $44,500 per dayFile correction immediately
Record keepingMissing supplier declarations, composition records$37,500 per violationFive-year record audit
Restricted chemical importPCB, asbestos, restricted PFAS, methylene chloride end use$37,500 minimum, criminal referral on knowing violationRestricted list screening at PO stage

The penalty numbers above reflect 2025 adjusted civil penalty maxima under 40 CFR Part 19, which EPA updates annually for inflation. Actual negotiated penalties in most enforcement actions come in below the maximum, but the aggregate $4.3 million across 115 actions puts the average above $37,000 per case. That is the reality of TSCA enforcement right now.

 Container shipping terminal at a major US port with dozens of dangerous goods containers awaiting CBP and EPA inspection

Where Chinese-Origin Chemicals Are Most Exposed

In our twenty years importing out of China, we have seen the same TSCA risk patterns recur across the chemistry we bring in. A few categories sit at the top of the EPA attention list, and a proposed use-specific framework will intensify scrutiny on each.

Industrial solvents sourced from Chinese petrochemical complexes are a perennial focus. EPA has active risk evaluations or restrictions on methylene chloride, 1-bromopropane, perchloroethylene, trichloroethylene and n-methylpyrrolidone. Chinese suppliers still market these to US importers regularly, and your purchase order paperwork needs to match EPA’s current status on each CAS number rather than the status from two years ago.

Surfactants and per-fluorinated chemistry is the fastest-moving bucket. PFAS rules under TSCA have expanded significantly, and any import of a fluorinated chemistry from a Shandong or Jiangsu plant needs a current Section 8(a)(7) check. The scope of regulated PFAS keeps growing, and importers who rely on a 2023 opinion letter from their broker are probably out of date.

Plasticisers and phthalates show up on consumer product risk evaluations. If your chemical feeds into toys, cosmetics, food contact or medical devices, the use-specific framework in the proposed rule will let EPA target downstream uses individually even if the plasticiser itself passes industrial review.

Flame retardants, particularly brominated and chlorinated families, have been on the EPA priority list for over a decade. Chinese manufacturers still produce a wide range of them, and US demand in electronics and building products keeps the import pipeline open. Expect use-specific restrictions in the next evaluation cycle.

Landed Cost Maths on a TSCA Compliance Programme

The question every chemical importer asks when a new compliance regime lands is whether the cost of compliance outweighs the cost of non-compliance. For TSCA, the maths is clear.

Consider an importer moving 2,000 tonnes per year of an industrial solvent from Wanhua or Sinopec at a landed price of $1,900 per tonne. Annual revenue on that single chemical is $3.8 million. A single EPA enforcement action at the average observed penalty of $37,000 is about one percent of revenue on that line. A programme that results in a restriction or ban on the chemical removes the revenue entirely and forces a reformulation that can cost $200,000 to $800,000 depending on how downstream customers are qualified.

The table below shows the rough cost of a credible TSCA compliance programme against the cost of a single serious enforcement event.

Programme ComponentAnnual CostOne-Off Cost
In-house TSCA specialist, part allocation$45,000
Third-party TSCA audit, annual$18,000
PMN filings, ten per year at legal review$60,000
Chemical Data Reporting cycle$12,000
Supplier compliance documentation, ongoing$22,000
Initial inventory reconciliation$35,000
Product reformulation on enforcement$500,000
Legal defence on a single enforcement action$75,000

A credible compliance programme runs about $157,000 per year plus an initial $35,000 setup. A single serious enforcement event costs $575,000 on average. The maths is not close. And that is before the downstream commercial damage of a customer finding out their supplier has an EPA violation on file.

 Oil refinery aerial in Louisiana with processing towers and storage tanks illustrating scale of US industrial chemical demand

What to Do Between Now and the Rule Finalisation

EPA will digest the comment docket through late 2025 and into early 2026, and a final rule is plausible by mid-2026 under a 180-day internal review cycle. That gives you roughly nine months to position your import programme for the new framework.

Conduct a full CAS number audit of every chemical you imported in the last three years. Export the data from your customs broker’s ACE records and match each CAS against the current TSCA Inventory, the SNUR list, the PFAS list, and the active risk evaluation list. Any chemical not on the Inventory needs an immediate review. Any chemical on a SNUR or risk evaluation list needs a use-case verification.

Get written supplier declarations from every Chinese manufacturer in your top twenty suppliers. The declaration should state the CAS numbers present in each product grade, the purity, the impurity profile, and any byproducts that could fall under TSCA. Chinese suppliers in Shandong, Jiangsu and Zhejiang are generally willing to provide this documentation, but you need to ask in writing and in Mandarin through a qualified agent.

Review your Section 13 import certification template with your customs broker. The certification has to be accurate at the moment of entry, and the proposed rule will give EPA more granular grounds to challenge a certification after the fact. Your template should capture the specific intended use, not just a generic “industrial use” box-tick.

File comments with EPA even though the docket has closed, by submitting supplementary data through the informal channels EPA maintains. If the use-specific framework would harm a legitimate industrial use of a chemical you import, EPA’s economic analysis needs to see the numbers. Industry associations like the American Chemistry Council and the Society of Chemical Manufacturers and Affiliates are both actively building supplementary submissions.

Build a scenario plan for your top five chemical imports. For each, model what happens if EPA uses the new framework to restrict one specific downstream use while allowing others. Where would your existing customers sit? Which customers would need reformulation support? Which suppliers in China could adjust grade specifications to meet the remaining allowed uses?

The Enforcement Vector Is Narrowing

EPA’s 2025 pattern is consistent. The agency is prioritising importers over domestic manufacturers because the enforcement leverage is cleaner on imports, the Section 13 certification is a discrete checkpoint, and CBP cooperation gives the agency real-time visibility into shipment flows. The 115 enforcement actions since January reflect that targeting strategy.

Under the proposed rule, the leverage gets cleaner still. If EPA can restrict a chemical for a specific use only, the burden falls on the importer to prove their shipment matches an allowed use rather than a restricted one. The certification language needed to make that proof is not yet finalised, but every broker we have spoken to in LA, Long Beach and Houston expects the Section 13 template to get longer and more detailed within twelve months of the final rule.

That means the ACE filing template you are using today is almost certainly going to be obsolete by Q3 2026. The suppliers who can give you clean composition and use-case documentation today will be the suppliers who still have working relationships with you in 2027. The suppliers who cannot will quietly drop off your approved vendor list, because the EPA risk of continuing to buy from them will not be worth the savings.

Your Next Move This Week

Pull the CAS number list from your last twelve months of CBP entries and cross-match against the current TSCA active risk evaluations list and the PFAS list. If any of your CAS numbers come up as a match or near-match, flag those imports for a deeper review before your next purchase order cycle.

Email your compliance lead and ask for a written status on the last CDR cycle filing. If there is any ambiguity about whether a filing went in, a voluntary correction now is cheaper than an EPA discovery later.

Sourzi runs TSCA compliance audits for US chemical importers sourcing from China, covering CAS number reconciliation, supplier documentation verification and ACE filing template review. If the September proposed rule is not yet on your Q4 agenda, we should talk this week.

SE

Sourzi Editorial

Sourzi Trade Intelligence

20 years of China trade. Direct sourcing, documentation, and factory relationships from Shanghai Pudong.

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