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Compliance

TSCA chemical inventory & PMN

Toxic Substances Control Act — Inventory, Premanufacture Notice and Chemical Data Reporting · Toxic Substances Control Act · Section 5 PMN · TSCA CDR · SNUR · Lautenberg amendments

In short

Term — TSCA Inventory and Pre-Manufacture Notification: tSCA framework — active/inactive Inventory after 2018 Reset, Section 5 PMN with mandatory EPA affirmative determination post-Lautenberg, Low Volume Exemption and Polymer Exemption pathways, Section 8(a) CDR four-year cycle, Section 6 risk evaluation with workplace chemical protection programmes, Section 13 import certification and Section 12(b) export notification.

TSCA (15 USC §2601) governs industrial chemicals manufactured, imported or processed in the US. The 2016 Frank R. Lautenberg amendments rewrote Sections 4, 5 and 6 and made the active/inactive TSCA Inventory mandatory. New chemicals — not on the active Inventory — require a Section 5 Premanufacture Notice 90 days before commercial launch with an EPA affirmative determination ('not likely to present unreasonable risk', 'may present' typically with 5(e) Consent Order, or 'insufficient information' 5(e) order). Low Volume Exemption (≤10,000 kg/yr) and Polymer Exemption (40 CFR 723.250 two-of-three criteria) provide expedited pathways. Significant New Use Rules (SNURs) extend Section 5 obligations to existing chemicals. Section 8(a) Chemical Data Reporting (40 CFR Part 711) operates on a four-year cycle with production volume, processing/use data and worker exposure information for substances above the 25,000 lb/site threshold. Section 6 risk evaluation runs prioritisation → evaluation → risk management with workplace chemical protection programmes (WCPP) including action levels, exposure limits and PPE. Section 13 requires positive or negative TSCA certification at every CBP import entry; Section 12(b) requires one-time-per-country export notification for substances subject to Section 4/5/6/7 actions. PFAS-specific actions including the 2023 Section 8(a)(7) one-time reporting rule and long-chain PFAS SNUR are particularly active enforcement areas.

Regulatory anchors
  • 15 USC §2601
  • 40 CFR Part 707
  • 40 CFR Part 711
  • 40 CFR Part 723.250
  • Frank R. Lautenberg Chemical Safety Act 2016
Where this term comes up
ChemicalsPlastics & ResinsAg ChemicalsConsumer Products
How V5 handles it
Score your compliance gap — then download the validation pack.
A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.
Document control — one version in force, every change signed and explained.
Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.
Supplier portal — chase nothing. Score everything.
Suppliers log in, see what you need, submit it against your spec, and watch their scorecard. SCARs are raised, replied to and closed in the portal — not in your inbox.
Software that covers TSCA chemical inventory & PMN
V5 Ultimate MRP Software
V5 Ultimate MRP runs the classic material-requirements engine — BOM explosion, gross-to-net, time-phased POs and work orders — on…
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