A Section 5 PMN is the filing a US manufacturer or importer must submit to the EPA before manufacturing or importing a chemical substance that is not on the TSCA Inventory. It is the on-ramp for new chemicals into US commerce. The EPA has a 90-day statutory review window, extendable to 180 days for complex cases, during which they can prohibit the introduction, require testing, impose use restrictions, or let the chemical proceed to commercial use.
When a PMN is required
If your imported chemical resolves to a CAS number that is not on the TSCA Inventory, you have three paths:
- PMN filing. Standard process for new chemicals intended for commercial use.
- Low Volume Exemption (LVE). Under 10,000 kg per year, simpler 30-day review, must commit to staying under volume.
- TSCA exemption category. R&D samples, articles, polymers meeting the polymer exemption criteria, and a small set of other categories may be exempt, but each exemption has conditions and the importer must self-certify against them.
For routine commercial chemical imports, the PMN is the norm. The LVE works for specialty or niche substances. The exemptions cover narrow cases.
What a PMN dossier contains
A complete PMN includes:
- Substance identity (CAS number if assigned, structural formula, manufacturing process)
- Intended use, including downstream applications and exposure scenarios
- Production volume (anticipated annual)
- Physical / chemical / toxicological data (where available, some PMNs are submitted with limited data and the EPA proceeds with conservative assumptions)
- Worker exposure scenarios at the importer’s site
- Disposal pathway
If the EPA judges the available data insufficient, they can issue a Section 5(e) Order requiring testing before commercial introduction proceeds. Section 5(e) Orders are common, over half of PMN reviews result in some form of EPA action, even if the action is mild.
SNURs and the post-PMN reality
After a PMN clears, the EPA frequently issues a Significant New Use Rule (SNUR) that locks in the conditions of the original PMN as binding regulation. The SNUR means: any future use of the substance outside the conditions of the original PMN requires a new filing. Buyers downstream of the original PMN holder need to verify their use fits within the SNUR scope, using the chemical for a different application than the one cleared can trigger another PMN obligation on the new user.
Practical sourcing notes
For US-bound chemical shipments, before booking we confirm: the substance is on the TSCA Inventory (preferred path), or it has a cleared PMN with a SNUR scope that covers the importer’s intended use, or the importer has filed an LVE or applicable exemption. We do not ship a substance to a US importer who has not addressed the PMN question. The cargo will sit at the port until cleared.
The 90-day statutory clock is firm, the EPA cannot legally delay beyond 180 days, but the importer’s own review and filing process before submission typically takes another 30 to 60 days. Plan a four-month runway for any new-chemical introduction.
LVE and other exemption pathways
Section 5 of TSCA includes several exemption pathways that can substantially reduce the PMN burden for low-volume or low-risk chemicals. The Low Volume Exemption (LVE) covers production or import volumes under 10,000 kg per year and replaces the full PMN with a 30-day notification at lower fee. The Low Release and Exposure Exemption (LoREX) covers chemicals with limited environmental release and worker exposure profiles. The Polymer Exemption covers most polymeric substances meeting EPA’s polymer-exemption criteria. Each exemption has its own filing requirements and its own ongoing reporting obligations once granted.
For a US importer evaluating a new-chemical introduction from China, the practical path is to assess whether any exemption applies before defaulting to a full PMN. The Polymer Exemption in particular is widely used because most novel polymeric materials qualify and the fee and review burden is meaningfully lower than full PMN. A regulatory consultant familiar with the exemption landscape typically charges USD 1,500 to USD 4,000 to assess applicability and prepare the filing; the cost is recovered against the avoided PMN fee within the first import.
Section 5 Notice of Commencement
Once a PMN is cleared and commercial introduction begins, the importer must file a Notice of Commencement (NOC) with EPA within 30 days of the first commercial shipment. The NOC triggers the chemical’s addition to the TSCA Inventory; missing the NOC filing means the chemical does not transition from PMN status to inventory listing, which creates ambiguity for subsequent shipments. The NOC is a simple filing but is one of the most-missed compliance steps in the Section 5 chain.
Related terms
TSCA is the parent statute. CDR is the four-year reporting cycle that captures volumes once a chemical is in commerce. MSDS Section 15 should reflect any SNUR conditions on a previously cleared substance.