INTERNATIONAL TRADE LAW

How to Import Chemicals: TSCA and EPA Compliance

To import chemicals into the United States, you must file a TSCA Section 13 import certification with U.S. Customs and Border Protection — certifying that each substance either complies with the Toxic Substances Control Act (a “positive” certification) or is not subject to it (a “negative” certification) — on top of the normal customs entry. Which certification applies, and what else you need, depends on what the chemical is and how it is regulated. This guide explains the certification, the TSCA Inventory check behind it, and the other agencies that may be involved.

File the TSCA Section 13 Import Certification

The core requirement comes from Section 13 of TSCA (15 U.S.C. § 2612), implemented by CBP in consultation with EPA at 19 C.F.R. §§ 12.118–12.127. Importers of chemical substances — including chemicals in mixtures — must certify at entry which of two statements is true.

CertificationWhen it appliesWhat you are saying
PositiveThe substance is subject to TSCA“I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA…”
NegativeThe substance is not subject to TSCA“I certify that all chemicals in this shipment are not subject to TSCA.”

The certification is signed and filed electronically (or in writing) with CBP by the importer or an authorized agent and must include the certifier’s name, email, and phone number. A negative certification is used when the substance is regulated by a different statute instead — for example a pesticide under FIFRA, or a food, drug, or cosmetic under the FDCA.

Confirm the Substance Is on the TSCA Inventory

A positive certification is only truthful if the chemical is actually allowed onto the U.S. market. That generally means the substance is listed on the TSCA Inventory of existing chemicals, or qualifies for an exemption. A substance that is not on the Inventory is a new chemical, and importing it requires submitting a Premanufacture Notice (PMN) to EPA — generally at least 90 days before import — so EPA can review it. Importing a new chemical without clearing the PMN process is a TSCA violation, so the Inventory check has to happen before you certify, not after.

Know Which Agency Actually Governs Your Chemical

“Chemicals” spans several regulatory regimes, and the right move is to identify the governing agency before entry. Getting the HTS classification right helps flag which rules attach.

  • Industrial chemicals → EPA under TSCA (the Section 13 certification above).
  • Pesticides and disinfectants → EPA under FIFRA, which requires product registration and an EPA Notice of Arrival (EPA Form 3540-1) before the shipment arrives. These take a negative TSCA certification.
  • Food additives, drug ingredients, color additives, cosmetics → FDA under the FDCA.
  • Hazardous materials in transit → DOT/PHMSA hazardous-materials rules (49 C.F.R.) govern packaging, marking, and shipping papers.

Handle Hazard Communication and Labeling

Many imported chemicals are hazardous substances that carry their own labeling and documentation duties once they are in commerce. Under OSHA’s Hazard Communication Standard, which is aligned with the Globally Harmonized System (GHS), hazardous chemicals need a compliant label (product identifier, signal word, hazard and precautionary statements, pictograms) and a Safety Data Sheet (SDS). For chemicals moving as dangerous goods, DOT marking and placarding apply during transport. See our overview of import labeling requirements for how these stack with customs marking.

Keep Records and Apply Reasonable Care

As with any entry, the importer of record is responsible under the duty of reasonable care (19 U.S.C. § 1484), and import records must be kept for five years under 19 U.S.C. § 1508. For chemicals, that record set should include the TSCA certification, the Inventory or exemption basis, SDSs, and any EPA submissions. CBP and EPA can both request this documentation, and a clean file is the difference between a routine customs audit and an enforcement case.

Frequently Asked Questions

What is a TSCA Section 13 import certification?

It is a statement filed with CBP at entry certifying that each imported chemical substance either complies with TSCA (positive certification) or is not subject to TSCA (negative certification). It is required under 15 U.S.C. § 2612 and 19 C.F.R. §§ 12.118–12.127.

What is the difference between a positive and negative certification?

A positive certification covers substances regulated under TSCA and states they comply with applicable TSCA rules. A negative certification covers substances outside TSCA — such as pesticides (FIFRA) or food, drug, and cosmetic ingredients (FDCA) — and states that TSCA does not apply.

What if my chemical is not on the TSCA Inventory?

It is treated as a new chemical, and you generally must submit a Premanufacture Notice to EPA — typically at least 90 days before import — and clear that review before bringing it in. Importing an unlisted new chemical without doing so violates TSCA.

Do imported pesticides follow the same rules?

No. Pesticides are regulated by EPA under FIFRA, which requires registration and an EPA Notice of Arrival before the shipment arrives, and they take a negative TSCA certification rather than a positive one.

Chemical imports turn on getting the certification and the governing-agency call right before the goods move. Reidel Law Firm helps importers sort TSCA, FIFRA, and FDA obligations on flat-fee terms, with a plain-English compliance memo and direct attorney access. Get an import compliance memo.

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