Introduction

Did you know that under the Toxic Substances Control Act (TSCA), a chemical substance manufacturer is defined to include importers? If you’re an importer, it means you need to meet the same TSCA provisions as manufacturers when you import chemicals, mixtures, or articles containing a chemical substance or mixture. If you fail to comply with any applicable TSCA rule or have any violation of TSCA, you cannot bring a chemical substance, mixture, or article into the customs territory of the U.S.

Importers must show that they are in TSCA compliance by certifying their imported chemical substances, mixtures, or articles that contain a chemical substance or mixture. This Fact File gives an overview of TSCA import certification.

Background

Your imports of chemical substances, mixtures, or articles that contain a chemical substance or mixture must comply with TSCA in order to enter the U.S. To ensure this is happening, EPA requires you to certify that imported chemicals either comply with TSCA (positive certification) or, if not otherwise clearly identified as a chemical excluded from TSCA, are not subject to TSCA (negative certification).

You’ll find the requirements in section 13 of TSCA (codified at 15 U.S.C. 2612) and in implementing regulations developed by the U.S. Customs and Border Protection (CBP) at 19 CFR 12.118 through 12.127. You’ll also want to check out EPA’s a companion chemical importing regulation at 40 CFR 707.

Who must certify?

As an importer, you or your authorized agent must:

• Sign and file a certification electronically with CBP via Automated Commercial Environment (ACE), or
• Provide a written paper certification that is typed, preprinted on the invoice, or otherwise included in the entry documentation and filed with the director of the port of entry before release of the shipment.

That 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. That even includes substances intended for research and development.

Certification statements

As an importer, your 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).

Applicable laws and regulations

19 CFR 12.118 to .127 — Chemical substances in bulk and as part of mixtures and articles

40 CFR 707 — Chemical imports and exports

5 U.S.C. 301 — Departmental regulations

15 U.S.C. 2611 — Exports

15 U.S.C. 2612 — Entry into customs territory of the United States

19 U.S.C. 66 — Rules and forms prescribed by Secretary

19 U.S.C. 1202 — Harmonizing tariff schedule

19 U.S.C. 1624 — General regulations

Related definitions

Article: A manufactured item: (1) which is formed to a specific shape or design during manufacture, (2) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.

Import: To import for commercial purposes.

Import for commercial purposes: To import with the purpose of obtaining an immediate or eventual commercial advantage for the importer, and includes the importation of any amount of a chemical substance or mixture. If a chemical substance or mixture containing impurities is imported for commercial purposes, then those impurities also are imported for commercial purposes.

Import in bulk form: To import a chemical substance (other than as part of a mixture or article) in any quantity, in cans, bottles, drums, barrels, packages, tanks, bags, or other containers, if the chemical substance is intended to be removed from the container and the substance has an end use or commercial purpose separate from the container.

Importer: (1) any person who imports any chemical substance or any chemical substance as part of a mixture or article into the customs territory of the United States, and includes: (i) The person primarily liable for the payment of any duties on the merchandise, or (ii) An authorized agent acting on his behalf. (2) Importer also includes, as appropriate: (i) The consignee. (ii) The importer of record. (iii) The actual owner if an actual owner's declaration and superseding bond have been filed in accordance with 19 CFR 141.20. (iv) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR 144. (3) For the purposes of this definition, the customs territory of the United States consists of the 50 States, Puerto Rico, and the District of Columbia.

Key to remember

Imports of chemical substances, mixtures, or articles that contain a chemical substance or mixture must comply with TSCA in order to enter the U.S. A certification must be signed and filed electronically or in writing with CBP by the importer or an authorized agent of the importer. No certification is required for chemicals that are a part of articles (unless required by a specific rule under TSCA) and tobacco or tobacco products.

Real-world examples

Here are some real-world enforcement case summaries:

• 2023 penalty amount $105,937 — Company failed to submit premanufacture notices at least 90 days before manufacturing (importing) chemicals which constitutes a failure to comply with section 5 of TSCA, 15 U.S.C. 2604, which is a prohibited act under section 15(1) of TSCA, 15 U.S.C. 2614(1). Company also informed EPA that it had manufactured (imported) polymer chemical substances between the calendar years 2018 and 2021 and had failed to comply with the recordkeeping regulations at 40 C.F.R. 723.250(j). Company also failed to submit proper certifications under section 13 of TSCA prior to importing chemical substances which constitutes a failure to comply with section 13 of TSCA, which is a prohibited act under section 15(3)(B) of TSCA, 15 U.S.C. 2614(3)(B).
• 2022 penalty amount $327,334 — EPA entered into an administrative Consent Agreement and Final Order with the company resolving TSCA Section 5 Premanufacture Notice, Section 13 Import Certifications, and Section 15(2) Commercial Use violations. EPA’s settlement includes the payment of a civil penalty of $327,334 and allows use of the existing stocks of the chemical under specific terms and conditions.
• 2022 penalty amount $513,450 — Company filed a voluntary disclosure of potential noncompliance via the EPA’s eDisclosure Voluntary Disclosure System identifying potential noncompliance with section 5 and 13 of TSCA but continued to process, use, and distribute existing stocks of the chemical product during the agency's review of the Significant New Use Notification (SNUN), in violation of section 15(2) of TSCA.