USEPA – TSCA Chemical Importation

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The Toxic Substances Control Act (TSCA) was first enacted in 1976 and serves as the Nation’s primary chemical management law, providing the US Environmental Protection Agency (EPA) with authority to require reporting, record-keeping, and testing requirements, as well as restrictions relating to chemical substances and mixtures. Furthering its impact, in June 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Lautenberg Act) to amend TSCA by strengthening EPA’s authority to manage existing and new chemical substances in commerce. 

As TSCA currently exists, chemical substances are first, classified into existing and new substances and then, inventoried accordingly.  Using this chemical library, the public can now quickly determine whether a chemical is on the inventory and if so, whether the substance is considered an existing chemical substance in US commerce. Any chemical that is not on the inventory, is considered a new chemical substance and only becomes an existing substance once EPA completes a risk assessment review.  As a result, the TSCA inventory is continuously growing as new chemicals are added, with the list now consisting of about 86,000 chemicals. The Lautenberg Act also significantly altered the ways in which EPA evaluates both existing and new chemicals with numerous clearance steps added to the process.

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Obligations Relating to Existing Chemical Substances

For existing chemical substances, listed on the US TSCA Inventory, the manufacturers/importers are required to check whether there are any Import Certification Requirements (Certification), Chemical Data Reporting Rules (CDR) for their product and whether or not the chemical substance meets the Active-Inactive rule.

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Obligations Relating to New Chemical Substances

For new chemical substances that are not listed on the US TSCA Inventory, a Pre-manufacture Notice (PMN) must be submitted to EPA at least 90 days before manufacturing (including importing) of the substance for a non-exempt commercial purpose.

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TSCA Import Certification Requirements

Importation 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 US. Importers must also 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).

The requirements are described in section 13 of the Toxic Substances Control Act (TSCA) (15 USC. 2612) and in implementing regulations developed by the US 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).

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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 with certification necessary for substances that are imported, whether received by mail or commercial carrier, including those chemicals intended for research and development.

Certifications filed electronically must be filed in the Automated Commercial Environment (ACE) while paper certification requires that the statement be 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.

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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

Þ 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.

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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 the following products when not clearly identified:

· 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

Note that these products may be considered clearly identified when they are associated with another relevant agency’s entry documentation or electronic entry filing requirements (e.g., Notice of Arrival for pesticides or applicable entry documentation for FDA regulated products).

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