TSCA Compliance

The Toxic Substances Control Act TSCA or TSCA compliance is a law laid down by the United States Congress in 1976, which regulates the introduction of any new or already existing chemicals. The administration of TSCA is done by the Environmental Protection Agency (EPA) with authority that requires reporting, record-keeping, testing requirements and restrictions relating to chemical substances and/or mixtures.

The TSCA aims to protect human health and environment. TSCA authorizes EPA to lay down rules requiring the testing of specific chemicals and to establish strict regulations that restrict the manufacturing, processing, distribution in commerce, use and disposal of chemicals and mixtures.

TSCA PBT Update

On January 6, 2021, EPA regulated usage of certain chemicals that are Persistent, Bioaccumulative and Toxic (PBT), under the section 6(h) of Toxic Substances Control Act (TSCA), amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. These chemicals get accumulated in the in the environment over time and can have potential risks for general population, consumers and commercial users (including children, workers and tribes).

The five chemicals added under the TSCA Section 6(h) are listed below along with their effective date:

  • Decabromodiphenyl ether (DecaBDE) – Manufacturing and distribution of DecaBDE containing products or articles is fully prohibited, effective date for Manufacturing -March 8,2021 and Distribution -January 6, 2022
  • Phenol, Isopropylated Phosphate (PIP) 3:1 – Processing and distribution of PIP 3:1 containing products or articles is fully prohibited, effective date from March 8, 2021 (delayed for 180 days)
  • hexachlorobutadiene (HCBD) – Manufacturing, processing and distribution of HCBD or HCBD-containing products or articles is fully prohibited. Effective date from March 8, 2021
  • pentachlorothiophenol (PCTP) – Manufacturing and processing of PCTP or PCTP-containing products or articles is prohibited unless concentrations are ≤ 1%, effective date from March 8, 2021. Distribution of PCTP or PCTP-containing products or articles is effective date from January 6, 2022.
  • 2,4,6-Tris(tert-butyl) phenol (2,4,6-TTBP) – Distribution in containers with a volume of less than 35 gallons (prohibited concentrations ≤ 0.3%). Processing and distribution of oil and lubricant additives. Effective date from Jan 6, 2026.

Out of the 5 restricted PBT’s, PIP 3:1 is of the major concern for many manufacturers, because of its widespread use in electronics. Another very commonly used substance in electronic products is DecaBDE; but as that is also listed as an SVHC under EU REACH, its usage has reduced over time. As on these effective dates, manufacturers are prohibited to use DecaBDE, PIP and HCBD substances in their products manufactured or sold in the US, and any violations can cause strict penalties.

You can read about the new TSCA Compliance PBT Regulation update in our blog here.

Who is Subject to TSCA Training Requirements?

All manufacturers, importers, processes, distributes in commerce that uses, or disposes of a chemical substance are subject to TSCA requirement. It could be any individual, corporation, partnership, or association, any State or political subdivision thereof, or any municipality, any body and department, agency, or instrumentality of the Federal Government.

Almost all companies across most industries are subject to a new, one-time reporting requirement imposed by the amended Toxic Substances Control Act (TSCA).

TSCA Reporting

What you should know about the TSCA reporting requirement?

  • The manufacturer and importer are legally bound to report the chemicals it uses and/or imports, even if its affiliates or other companies have reported the same substance.
  • Reporting is not required for food, pesticides, cosmetics, drugs, R&D materials medical devices, impurities, byproducts that are disposed (and not used) and some naturally occurring substances.

Companies are liable to report each chemical separately that makes up an imported mixture as well as substances that are made — intentionally or not — through secondary or recovery processes and reused in some way.

How can you Determine If a Chemical Is Compliant with TSCA?

Firstly, you must check whether the chemical substance in your product is listed on the TSCA Inventory of Chemical Substances. A chemical substance that is not listed on TSCA Inventory is regarded as a new substance and are subject to pre-manufacture notice requirement (PMN) prior to its import.

Secondly, you have to check whether the chemical substance in your product is subject to Significant New Use Rules (SNURs) requirements under TSCA. Substances that are subject to SNUR requirements are designated by an “S” flag in the TSCA Inventory listing. If your substance is subject to a SNUR and your intended manufacture, processing, or use of the substance is a significant new use, you are required to submit a Significant New Use Notice (SNUN) 90 days prior to the manufacture of that substance.

US TSCA Regulatory

Thirdly, you shall check if your products comply with TSCA restriction requirements on Polychlorinated Biphenyls (PCBs) and Asbestos.

What are the TSCA Import Certification Requirements

All Imported chemicals substances, mixtures or articles that contain a chemical substance or mixture must comply with the Toxic Substances Control Act (TSCA).

The following are two type of Certification :

  • Positive Certification: If the imported chemicals comply with the TSCA.

    The following statement goes with positive certification-

    “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

  • Negative Certification: If the imported chemical is excluded from TSCA and are not subjected to TSCA

The following statement goes with negative certification –

“I certify that all chemicals in this shipment are not subject to TSCA.”

A negative certification is required to be given by the importer for the following products when not clearly identified:

  • Any food, food additive, drug, cosmetic or device
  • Any pesticide
  • Source material, special nuclear material, or by-product material
  • Firearms and ammunitions as defined in section 3 of TSCA

All the certifications is required to be duly signed and filed electronically or in writing with CBP by the importer or an authorised agent of the importer.

Certifications filed electronically are required to be filed in the Automated Commercial Environment (ACE).

Want to know more about TSCA compliance reporting requirement & Perform TSCA compliance audits and training? Talk to one of our TSCA Specialist today!