Section 5-Related Import and Export Requirements
This Web page summarizes how various import and export requirements and exemptions can apply to new chemicals and significant new uses of chemicals that are subject to Section 5 of TSCA. More information on these topics may be found on the TSCA Import-Export Requirements Homepage and New Chemicals Homepage.
- TSCA Section 5 Pre-Manufacture Notice Requirement for Import of New Chemicals/Uses
- Import Requirements in TSCA Section 5(e) Orders and Section 5(a)(2) Significant New Use Rules
- TSCA Section 13 Import Certification Requirement for Import of New Chemicals
- TSCA Section 12(b) Export Notice Requirement
- TSCA Section 12(a) Export Exemption
TSCA Section 3(7) defines the term "manufacture" to include import. This means that the Section 5(a)(1)(A) requirement to submit a pre-manufacture notice ("PMN") to EPA at least 90-days before commencing non-exempt commercial manufacture of a new chemical substance in the United States applies to import of new chemicals, as does the Section 5(a)(1)(B) 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 Part 720
- Significant new use notice provisions in 40 CFR Part 721
- Premanufacture notice exemptions for new chemicals in 40 CFR Part 723
- Reporting requirements for inter-generic microorganisms in 40 CFR Part 725
When appropriate, EPA issues Section 5 regulatory requirements on new chemicals or significant new uses of chemicals via a TSCA Section5(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 Material Safety Data Sheet (MSDS) requirements, restrictions on the amount of the chemical allowed to be manufactured or 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, 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 MSDS requirements
- Not exceed any specified restrictions on permissible import volume
- Not be imported for any designated significant new use
- Comply with any other applicable requirements
To make a "positive" certification under TSCA Section 13 and 19 CFR 12.118 to 12.127 et. seq. that "all chemical substances in this shipment comply with all applicable rules or orders under TSCA" means that the shipment complies with all the following requirements when applicable to the specific shipment:
- Section 5(a)(1)(A) Pre-Manufacture Notice (PMN)
- Section 5(a)(1)(B) Significant New Use Notice (SNUN)
- Section 5(e) Order
- Section 5(f) Rule or Order
- Section 6 Rule or Order
- Section 7 Judicial Action
- Title IV Rules and Orders
The export notice requirement under TSCA Section 12(b) and 40 CFR 707 Subpart D applies to chemicals for which EPA has issued any of the following regulatory actions:
- Testing requirement under Section 4
- Section 5(e) Order
- Section 5(a)(2) proposed or final Significant New Use Rule
- Section 5(f) Order
- Section 5(f) proposed or final rule
- Section 6 proposed or final rule
TSCA Section 12(a) Export Exemption
Under TSCA Section 12(a) and 40 CFR 720.30(e), a new chemical substance is exempt from the PMN requirement if it is manufactured solely for export and if, when the substance is distributed in commerce:
(1) The substance is labeled "for export" in accordance with Section 12(a)(1)(B) of the Act; andFurther Information
(2) The manufacturer knows that the person to whom the substance is being distributed intends to export it or process it solely for export as defined in 40 CFR 721.3.
For additional information visit the TSCA Import-Export Requirements Homepage.
For more information on the TSCA Section 5 New Chemicals Program, visit the TSCA New Chemicals Homepage.