TSCA Requirements for Importing Chemicals
- TSCA import certification requirements
- Who must certify
- Certification statements
- Section 6 TSCA Requirements for specific chemicals
- Import of new chemicals and new uses of chemicals
- Import requirements in TSCA section 5(e) orders and section 5(a)(2) Significant New Use Rules
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 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 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).
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.
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)
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.
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
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.
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:
- 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
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
Importation of TSCA Title VI Regulated Articles (Formaldehyde Emission Standards for Composite Wood Products)
The TSCA Title VI import certification requirement applies to composite wood products (i.e., panels of hardwood plywood, particleboard, medium density fiberboard, and thin-medium density fiberboard), component parts containing such composite wood products, and finished goods containing such composite wood products that are imported into the U.S. beginning March 22, 2019.
Under the TSCA Title VI regulation, importers must also:
- Keep Records. Take reasonable precautions by retaining, for three years, bills of lading, invoices, or comparable documents that include a written statement from the supplier that the composite wood products (or component parts/finished goods) are TSCA Title VI compliant.
- Provide Records on Request. When EPA requests, make available within 30 days records identifying 1) the panel producer and the date the composite wood products were produced; and 2) records identifying the supplier, if different, and the date the composite wood products (or component parts/finished goods) were purchased.