What Is the Toxic Substances Control Act?

The Toxic Substances Control Act (TSCA) was first enacted in 1976, with the aim of regulating the presence of hazardous substances in U.S. commerce. However, it was significantly updated under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which added new restrictions while keeping the old obligations. This updated set of requirements is often known as New TSCA.

New TSCA introduced an evolving list of restricted substances and a new set of communication requirements. These changes also introduced new risks, including updated enforcement penalties and potential jail time for individuals that are knowingly or willfully non-compliant. The ability to quickly identify and replace restricted substances has become paramount. For a summary of the current TSCA regulations, check out our TSCA handbook.

While TSCA regulates products in U.S. commerce, the scope of the act also affects any global manufacturers doing business in the U.S. Therefore, companies in the European Union (EU) and other global regions should also pay close attention to TSCA requirements.

Companies often underestimate TSCA’s impact. Most only see an Environmental Protection Agency (EPA) shortlist of five restricted substances without realizing there are long lists of other high-risk substances that they should expect to see added to restricted lists.

What Chemicals Are Subject to TSCA?

The Toxic Substances Control Act regulates substances that are determined to have significant harmful effects on human health and the environment. The TSCA Inventory and restricted substances list are maintained by the EPA.

Substance lists under TSCA are often a source of confusion for companies looking to understand their compliance requirements because it is necessary to comply with both the TSCA Inventory (containing over 86,000 chemicals) and the dynamic TSCA Section 6 restrictions list, which currently contains 14 substances and is expected to rapidly expand over the next several years.

On January 6, 2021, the EPA added five substances to the restricted list:

  • Phenol, Isopropylated Phosphate (3:1) (PIP 3:1)
  • Decabromodiphenyl ether (DecaBDE)
  • 2,4,6-Tri-tert-butylphenol (2,4,6 TTBP)
  • Hexachlorobutadiene (HCBD)
  • Pentachlorothiophenol (PCTP)

The best practice is to regularly monitor the EPA’s notifications to ensure you receive updates and understand which chemicals are subject to TSCA.

To learn more about the TSCA restricted substances and their compliance deadlines, check out Assent’s article “What is TSCA?”

What Are TSCA PFAS Requirements?

In June 2021, the EPA announced three actions regarding per- and poly-fluoroalkyl substances (PFAS), such as PFOA (perfluorooctanoic acid), PFOS (prefluorooctyl sulfonate), and LCPFAC (long-chain perfluoroalkyl carboxylate) substances:

  1. Proposed reporting for products containing PFAS that are manufactured or imported in the U.S.
  2. Eliminated guidance that weakened the Significant New Use Rule (SNUR) regarding long-chain PFAS.
  3. Required Toxics Release Inventory (TRI) reporting on three additional PFAS substances.

Many older PFAS are no longer manufactured in the U.S. following numerous government phase outs and restrictions. However, PFAS still enters U.S. commerce, primarily through import, and therefore the EPA regulates its presence in supply chains.

Compliance with TSCA’s rules for PFAS requires your business to be aware of fluorinated materials in your products, and to educate your suppliers about TSCA requirements. Suppliers outside the U.S. may not have the same PFAS restrictions and would not be aware of the compliance risks their products hold for you. Assent works with your suppliers to keep them up to date with TSCA changes and ensure they are contributing to your compliance efforts.

What Do TSCA Sections 8c & 8e Regulate?

TSCA Section 8(c) and 8(e) focus on the recordkeeping and reporting of adverse health and environmental effects of substances:

  • 8(c) requires manufacturers, importers, and processors of chemical substances to maintain records of alleged significant adverse reactions to human health or the environment caused by those substances.
  • 8(e) requires those entities who obtain evidence that a certain substance poses a substantial risk to health or the environment to notify the EPA.

These two sections are designed to give the EPA an “early warning” system that will help them manage and maintain the TSCA list of materials.

However, these sections represent only a small subset of your TSCA reporting requirements. In addition to documenting potential hazards, under TSCA Section 6(h) you must also diligently monitor your supply chain to ensure there are no banned or restricted substances in your product.

This is where taking a proactive approach to compliance is vital – knowing if your suppliers are using TSCA-restricted substances requires constant communication. Companies that fail to comply in time can face fines of up to $50,000 USD per day of violation and imprisonment of up to one year.

What Does It Mean To Be TSCA Title VI Compliant?

TSCA Title VI, also known as the California Air Resources Board (CARB) Airborne Toxic Control Measures (ATCM) Phase II, is a regulation that mandates the reduction of formaldehyde in wood products and outlines the third-party certification process to demonstrate compliance. To be TSCA Title VI compliant, wood products must undergo testing, certification, and labelling. Companies processing or otherwise using wood products should be aware of whether they are purchasing TSCA-compliant materials. You should ensure that your wood product suppliers have had their products tested and certified according to the CARB ATCM standard.

In addition to Title VI of TSCA, there are numerous other sections to be aware of. For any TSCA requirement, it is exceedingly difficult to be confident in your compliance status without supply chain transparency. We recommend implementing a system that automates supply chain data collection to improve visibility into the compliance status of materials coming from suppliers.

Watch the free on-demand webinar, TSCA Section 6 Roles & How to Comply, to learn about best practices for creating a proactive and reliable TSCA compliance program.


How to Comply With Customer Notification Requirements

The EPA requires downstream customer notification if TSCA restricted substances are present in your products, as these restrictions can impact product manufacturers, importers, distributors, and retailers. There is no standardized format, but the industry-standard best practices are to ensure the declaration:

  • Is on company letterhead.
  • Is dated.
  • References the appropriate TSCA section (e.g. Section 6(h)).
  • Indicates which TSCA restricted substance(s) are present in your product.
  • Includes a signature from an authorized employee.
  • Includes contact information.

The EPA requires that companies capture accurate supply chain data from upstream suppliers, communicate the presence of restricted substances to downstream customers, and retain this documentation for at least three years as evidence of due diligence.

Non-compliance with TSCA can lead to loss of U.S. market access and enforcement penalties. Companies may also face business risk from non-compliance due to supplier de-selection or breach of contract, if customers are not made aware of the presence of restricted substances. Assent automates supply chain data collection, demonstrating due diligence and giving you transparency into your TSCA compliance status.

How to Comply With TSCA

The Toxic Substances Control Act has multiple sections and requirements, all of which are grounded in knowing what goes into your product. To comply with TSCA, you will need to campaign your suppliers to learn what substances they are using, and educate them about TSCA requirements so that they can provide you with the information needed to show compliance. Supply chain risk mitigation requires that you monitor TSCA changes and prepare for any looming additions to the restricted list by ensuring you can rapidly query your supply chain for any substance.

Assent acts as a trusted partner to help with your TSCA requirements, keeping you up to date with the constantly-growing list of TSCA restrictions. We give you access to our team of regulatory experts and analysts who monitor the regulatory landscape to give you as much advanced notice about TSCA changes as possible. Although the TSCA list currently consists of only a few substances, the EPA is swiftly evaluating and planning to add more in the coming years. To learn more about how Assent can help you meet your TSCA requirements, contact our experts.

Dr. Bruce Jarnot
Regulatory & Sustainability Expert, Product Sustainability

Bruce is a board certified toxicologist with over 30 years of industry experience managing product safety and global materials compliance programs with large organizations,  Read More

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