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TSCA Import-Export Requirements

TSCA Requirements for Importing Chemicals

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TSCA Import Certification Requirements

Imports of chemical substances, mixtures or articles that contain a chemical substance or mixture must comply with the Toxic Substances Control Act (TSCA) in order to enter the U.S. Importers must certify that imported chemical substances either comply with TSCA (positive certification) or are not subject to TSCA (negative certification). Certain chemicals are excluded and certain chemicals require no certification.

The requirements are described in section 13 of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2612) and in implementing regulations developed by the U.S. Customs and Border Protection (CBP), in consultation with EPA, at 19 CFR 12.118 through 12.127. In addition, EPA has a companion policy statement on chemical imports at 40 CFR 707.20 (PDF) (3 pp, 183 kb).

Who Must Certify

A certification must be signed and filed electronically or in writing with CBP by the importer or an authorized agent of the importer. A certification must also include the certifier's name, email address, and telephone number. Certification is required for substances that are imported and are received by mail or commercial carrier, including those intended for research and development.

Certifications filed electronically must be filed in the Automated Commercial Environment (ACE).

For paper certification, the statement must be typed, preprinted on the invoice, or otherwise included in the entry documentation and must be filed with the director of the port of entry before release of the shipment.

Certification Statements

An importer's statement must certify either that the chemical shipment is:

  • subject to TSCA and complies with all applicable rules and orders (positive certification)
  • or that the chemical shipment is not subject to TSCA (negative certification)

Positive Certification Statement:

The following is a positive certification statement.

"I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order thereunder."

A positive certification means that the chemical substance complies with all applicable TSCA regulations, including:

  • Section 5 premanufacture notification rules
  • Section 5 significant new use rules
  • Section 5(e) orders
  • Section 5(f) rules and orders
  • Section 6 rules and orders
  • Section 7 judicial actions
  • Title IV rules and orders

Note that sections 4 and 8 rules do not pertain to section 13 import certification requirements. Although importers must satisfy all applicable requirements of sections 4 and 8 rules, compliance with those provisions is not related to individual chemical shipments and therefore does not affect import certification.

Negative Certification Statement:

The following is a negative certification statement.

"I certify that all chemicals in this shipment are not subject to TSCA."

A negative certification is required for:

  • Any pesticide
  • Any food, food additive, drug, cosmetic or device
  • Source material, special nuclear material, or by-product material
  • Firearms and ammunitions as defined in section 3 of TSCA

No certification is required for the following:

  • Chemicals that are a part of articles, unless required by a specific rule under TSCA
  • Tobacco or tobacco products

Section 6 TSCA Requirements for Specific Chemicals

Some chemicals have specific import and export requirements under section 6 of TSCA. These chemicals include, but aren't limited to PCBs, mercury, and, asbestos.

Import of New Chemicals and New Uses of Chemicals

TSCA section 3(7) defines the term "manufacture" to include import. This means that the section 5(a)(1)(B) 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 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:

Learn more about EPA's new chemicals program.

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 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