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What import and export requirements apply to new chemicals and significant new uses of chemicals under Toxic Substances Control Act (TSCA) Section 5-Related Import and Export Requirements?
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 5 Pre-Manufacture Notice Requirement for Import of New Chemicals/Uses 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 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 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 TSCA Section 13 Import Certification Requirement for Import of New Chemicals 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 TSCA Section12(b) Export Notice Requirement 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 The export notice requirement under TSCA Section 12(b) and 40 CFR 707 Subpart D also applies to chemicals for which judicial action is pending or relief has been granted under Sections 5 or 7. 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; and (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. Further Information 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.
Customs & Border Protection (CBP), Department of Homeland Security
http://www.cbp.gov/
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