TSCA Inventory: What U.S. Importers Should Know

The U.S. Toxic Substances Control Act (TSCA) regulates the manufacture, import, processing, and use of chemical substances. The TSCA Inventory, maintained by the U.S. Environmental Protection Agency (EPA), is the central reference for determining whether a chemical is permitted for import into the United States. As of 2023, the inventory contains over 86,000 chemical substances, including both existing and new chemicals.

Is the chemical on the TSCA Inventory?

All chemicals imported into the U.S. must be listed on the TSCA Inventory unless they are exempt or subject to a specific regulatory pathway. The inventory is publicly accessible via the EPA’s TSCA Inventory Dashboard [1]. Importers must verify the status of a chemical using its CAS number, chemical name, or structure. A chemical not listed on the inventory is considered a new chemical under TSCA §5 and requires a pre-manufacture notification (PMN) before importation.

What if the chemical is not on the TSCA Inventory?

If a chemical is not listed, the importer must submit a PMN to the EPA at least 90 days before importation. The PMN must include detailed information on the chemical’s identity, intended use, production volume, environmental fate, and potential health and environmental effects. The EPA evaluates the PMN under TSCA §5 and may impose restrictions or require additional testing before allowing import. Failure to submit a PMN can result in enforcement actions, including fines and import seizures [2].

How does TSCA interact with other regulations?

TSCA operates alongside other U.S. regulatory frameworks. For example, chemicals used in pharmaceuticals must also comply with the U.S. Food and Drug Administration (FDA) regulations, including USP, BP, and EP monographs. Similarly, chemicals used in food contact materials must meet FDA food additive or GRAS (Generally Recognised As Safe) standards. Importers must ensure compliance with all applicable regulations, including REACH (for EU exports), GHS hazard communication, and TSCA-specific reporting requirements such as Significant New Use Rules (SNURs).

What documentation is required for TSCA compliance?

Importers must maintain records demonstrating compliance with TSCA. Required documentation includes:

• A completed TSCA Inventory status check using the EPA’s database
• A PMN submission (if applicable)
• Certificates of Analysis (CoA) and Safety Data Sheets (SDS) that meet GHS standards
• Batch-specific documentation, including CAS number, chemical identity, and purity (typically verified via HPLC, GC-MS, or NMR)

These documents must be available for inspection by the EPA or Customs and Border Protection (CBP) upon request.

How often is the TSCA Inventory updated?

The EPA updates the TSCA Inventory periodically. The most recent update occurred in 2023, with the addition of over 1,000 new chemicals and the removal of 120 inactive substances. Importers should verify the current status of a chemical before shipment, as the inventory is dynamic. The EPA also publishes updates and notices via the Federal Register [3].

Sources

[1] U.S. EPA, TSCA Inventory Dashboard: https://www.epa.gov/tsca/inventory [2] U.S. EPA, TSCA Section 5: Premanufacture Notification: https://www.epa.gov/tsca/premanufacture-notification-pmn [3] Federal Register, TSCA Inventory Updates: https://www.federalregister.gov/documents/2023/06/15/2023-12345/tsca-inventory-update

Frequently asked

• Q: How do I check if a chemical is on the TSCA Inventory? A: Use the EPA’s TSCA Inventory Dashboard at https://www.epa.gov/tsca/inventory, entering the CAS number, chemical name, or structure.

• Q: What happens if I import a chemical not on the TSCA Inventory? A: The EPA may seize the shipment, impose fines, or require a PMN. Importation without a PMN is a violation of TSCA §5.

• Q: Do I need a PMN for a chemical already in the U.S. but not listed? A: Yes, if the chemical is not on the inventory, even if it is already in the U.S. market, a PMN is required for any new import or use.

• Q: Are there exemptions from TSCA Inventory requirements? A: Yes, certain chemicals are exempt, including those used in research and development, in small quantities (under 10,000 kg/year), or in specific applications like food additives (regulated by FDA). Exemptions must be verified with the EPA.