• Because imports are included in the definition of manufacture, importing chemical substances can trigger premanufacture notices, significant new use notices, and other requirements.

Section 3 of the Toxic Substances Control Act (TSCA) defines the term manufacture to include import. This means that the section 5(a)(1)(B) requirement to submit a premanufacture notice (PMN) to EPA at least 90-days before commencing non-exempt commercial manufacture of a new chemical substance in the U.S. applies to the import of new chemicals, as does the section 5(a)(2) significant new use notice (SNUN) requirement. Thus, the intended import of chemical substances can trigger the following provisions:

• Premanufacture notice provisions for new chemicals in 40 CFR 720;
• Significant new use notice provisions in 40 CFR 721;
• Premanufacture notice exemptions for new chemicals in 40 CFR 723; and
• Reporting requirements for inter-generic microorganisms in 40 CFR 725.

Import requirements in TSCA section 5(e) orders and section 5(a)(2) significant new use rules

When appropriate, EPA issues section 5 regulatory requirements on new chemicals or significant new uses of chemicals via a TSCA section 5(e) order or section 5(a)(2) significant new use rule (SNUR, 40 CFR Part 721 or 725 Subparts L and M).

TSCA section 5(e) orders may include use prohibitions, labeling and safety data sheet (SDS) requirements, restrictions on the amount of the chemical allowed to be manufactured (including imported), as well as other restrictions. (The import/production limits often serve as triggers for toxicity or related testing requirements.) SNURs require notifying EPA at least 90 days before manufacture (including import), or processing for uses/activities designated by EPA as a significant new use.

To comply with these requirements when applicable, chemical substances must:

• Not be imported for any prohibited use,
• Satisfy all applicable labeling and SDS requirements,
• Not exceed any specified restrictions on permissible import volume,
• Not be imported for any designated significant new use, and
• Comply with any other applicable requirements.