Regulation overview
EPA TSCA: The Toxic Substances Control Act
The Toxic Substances Control Act (TSCA) is the US federal law that lets the Environmental Protection Agency (EPA) review and regulate the manufacture, import, processing, distribution, use and disposal of chemical substances. Central to it is the TSCA Inventory of existing chemicals, which is why SDS Section 15 often states whether a substance is listed. TSCA is separate from OSHA's HazCom.
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Who it applies to
TSCA applies to companies that manufacture (including import) or process chemical substances in the United States, and to those who distribute, use or dispose of them. Importers have to certify that imported chemicals comply with TSCA. Certain categories are excluded because other laws cover them, including pesticides, foods, food additives, drugs, cosmetics, tobacco and some nuclear and firearms materials; those chemicals may be covered by other acts when used for those purposes. The 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act significantly amended TSCA, strengthening EPA's authority to evaluate existing chemicals.
What TSCA requires
- The TSCA Inventory. A list of chemical substances manufactured or processed in the US. A substance not on the inventory generally cannot be manufactured or imported for commercial purposes without notifying EPA or qualifying for an exemption.
- New chemical review. A premanufacture notice (PMN) or an exemption is needed before commercial manufacture or import of a new substance.
- Risk evaluation and management. EPA prioritizes existing chemicals, evaluates risks, and, if there is an unreasonable risk, can impose restrictions through rules (Section 6).
- Reporting. Periodic reporting such as Chemical Data Reporting for production and use, and reporting of certain health and safety studies and information indicating substantial risk (Section 8). Reporting and recordkeeping requirements apply to some substances; check the thresholds.
- Import and export. Import certification; export notification for some chemicals.
The details, thresholds and deadlines are in EPA's rules and change; do not rely on general summaries for compliance decisions.
TSCA and the safety data sheet
TSCA does not set an SDS format. But SDS Section 15 typically states whether each component is on the TSCA inventory, and may mention any TSCA Section 6 restrictions, Section 12(b) export notices or significant new use rules (SNURs) that apply. Because it is optional, the information can be incomplete. The status of "active" or "inactive" on the inventory affects whether a substance can be freely manufactured. For mixtures, sheets usually say that all components are listed or exempt.
Key differences versus OSHA HazCom
- Different agency, different aim. TSCA is administered by EPA and addresses risks to health and the environment from the chemical's life cycle; HazCom is administered by OSHA and addresses worker communication.
- Inventory and premarket review. TSCA includes a chemical inventory and a premarket review for new chemicals; HazCom has neither.
- Substance-based. TSCA is organized by chemical substance and its uses; HazCom by hazard classes and workplace communication.
- Closest EU analogue. EU REACH, which combines registration with SDS duties.
Practical points
- When importing or manufacturing, check the TSCA inventory status of every substance, including those in mixtures.
- Keep supplier statements of TSCA compliance with your records. See chemical inventory management.
- Look at Section 15 of your sheets, but verify with the EPA's official sources when compliance matters.
- Other US environmental rules also appear in Section 15; see SARA Title III and EPCRA.
Worked scenario: importing a new blend
A company plans to import a coating that contains three components. Before the first shipment, it asks the foreign supplier for the identity of each component and checks each against the TSCA inventory. Two are listed. The third is not, and the supplier will not disclose its identity because it is confidential. The importer must establish the third substance's status before bringing the product in, for example by working with the supplier on a confidential way to confirm its identity and inventory status to EPA. Importing first and sorting it out afterwards risks enforcement action and a stuck shipment.
Frequently asked questions
What is TSCA?
The Toxic Substances Control Act is the US law giving EPA authority to review, regulate and require reporting on industrial chemicals.
What is the TSCA inventory?
A list of chemical substances manufactured or processed in the US. Substances not on it generally need EPA notification or an exemption before commercial manufacture or import.
Does TSCA regulate pesticides and cosmetics?
No. TSCA excludes pesticides, foods, drugs, cosmetics and certain other items, which are covered by other laws.
Where do I see TSCA status on an SDS?
Usually in Section 15, Regulatory information, which often lists inventory status for each component.