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Import Requirements Under Tthe
Toxic Substances Control Act (TSCA)

October 8, 2009

In August, CBFANC offered a well attended seminar on the importation of chemicals and related products. One of the important topics discussed was compliance with the requirements of the Toxic Substances Control Act or “TSCA.”

Section 13 of TSCA requires that any chemical substance, mixture, or article containing a chemical substance or mixture (including microorganisms and mixtures) be refused entry if it fails to comply with TSCA, or is offered for entry in violation of section 5, 6, or 7 of TSCA. This engendered a discussion about when a TSCA certificate is required and when one is not.

EPA and Customs Regulations (40 CFR 707.20 and 19 CFR 12.120, respectively) require that importers “certify” that imported chemical substances or mixtures are either:

  1. In compliance with TSCA Sections 5, 6 and 7 at the time of import; or
  2. Not subject to TSCA.

Customs can refuse entry of any shipment that does not have a TSCA certification. Failure to have a certificate at the time of entry can be treated as a recordkeeping violation under 19 USC 1509(a) (1) (A) (and subject to a $10,000 penalty) or a false statement penalty under 19 USC 1592 equal to 20 to 40% of the value of the shipment. The inability to redeliver a shipment that is subject to a timely notice of redelivery can also result in the assessment of liquidated damages of three times the value.

A certification may be typed, preprinted on the invoice, or otherwise included in the entry documentation, or it may be provided to Customs at the port of entry as a blanket statement before release of the shipment. If a blanket statement is on file, the invoice must make reference to it.

Both Customs and EPA regulations provide that the certification is to be signed by the importer or the agent thereof. When a Certification is required, it must state either that the chemical shipment is subject to TSCA and complies with all applicable rules and orders thereunder or that the chemical shipment is not subject to TSCA.

If the “chemical substances” are in a class included in TSCA jurisdiction, you must make a positive TSCA statement. A positive certification means that the chemical substance complies with all applicable TSCA regulations, including:

  • Section 5 Pre-Manufacture 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

A negative certification means that the chemicals in the shipment are not subject to TSCA. A negative certification is applicable to:

  • Pesticides
  • Any food, food additive, drug, cosmetic or device
  • Source material, special nuclear material, or by-product material
  • Firearms and ammunitions

No certification is required for:

  • Chemicals that are a part of articles
  • Tobacco or any tobacco product

Currently, TSCA import certifications are not required for imports of articles. If, however, a chemical product or mixture is included as a part of the article (as in a set, kit or combination article), a certification may still be required.

Chemical substances and mixtures are considered to be a part of an article only if the substances or mixtures are not intended to be removed/ released from the article and they have no end use or commercial purpose separate from the article of which they are a part. See 42 FR 64583 (December 23, 1977).

The term “article” is defined [40 CFR sections 704.3, 710.2(e), and 720.3(c)] [19 CFR §12.120(a)] as a manufactured item which:

  1. Is formed to a specific shape or design during manufacture;
  2. Has end use functions dependent in whole or in part upon its shape or design during the end use, and

    • 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 may occur as described in § 12.120(a)(2); except that fluids and particles are not considered articles regardless of shape or design.

Chemical substances that are meant to be released from an article do not qualify for the article exemption. Ink in pens, glue or paint in a tube or container, and ink or toner in cartridges could all be characterized as substances meant to be released from an article, and so are not qualified for the article exemption. Therefore, importers of these substances, even in a kit with other items, would be required to make a positive TSCA certification.

Allowable changes of composition referred to in § 12.120(a)(1) are in many cases difficult to determine without clarification by EPA. Therefore, caution is advised before you and/or your client conclude that an item is excluded from the TSCA certification requirements because of § 12.120(a)(2).

You can find information on import requirements for new and existing chemicals subject to TSCA on their website at:

Information can also be found in the EPA publication, "Introduction to the Chemical Import Requirements of the Toxic Substances Control Act (PDF)"(11 pp., 97.7 kb), or by contacting our office.

For assistance or additional information, please contact George Tuttle, III at (415) 986-8780 or

George R. Tuttle, III is an attorney with the Law Offices of George R. Tuttle in San Francisco.

The information in this article is general in nature, and is not intended to constitute legal advice or to create an attorney-client relationship with respect to any event or occurrence, and may not be considered as such.

Copyright 2009 by Tuttle Law Offices.

All rights reserved. Information has been obtained from sources believed to be reliable. However, because of the possibility of human or mechanical error by our offices or by others, we do not guarantee the accuracy, adequacy, or completeness of any information and are not responsible for any errors, omissions, or for the results obtained from the use of such information.

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