Everything You Need To Know About TSCA 6(h)

What Is the Toxic Substances Control Act (TSCA)? 

The Toxic Substances Control Act (TSCA) of 1976 is a law that regulates the introduction of new or already existing chemicals in order to reduce risk to public health and the environment in the United States. Implemented during a decade of growing awareness about the ramifications of environmental pollution, TSCA is a critical piece of environmental regulation manufacturers and importers must comply with as part of bringing products to the U.S. market. 

What Is TSCA 6(h)?

TSCA Section 6 deals with various authorities given to the Environmental Protection Agency (EPA) to regulate chemicals. TSCA Section 6h refers to a provision within Section 6.

TSCA Section 6(h) was introduced as part of the amendments to the Toxic Substances Control Act (TSCA) in 2016. These amendments, known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, were signed into law on June 22, 2016. Section 6(h) specifically addresses Persistent, Bioaccumulative, and Toxic (PBT) chemicals and provides the Environmental Protection Agency (EPA) with authority to take action to regulate them. 

Bioaccumulation refers to the gradual accumulation of substances within an organism.

PBTs are substances that persist in the environment, bioaccumulate in living organisms, and pose risks to human health or the environment. Under Section 6(h), the EPA has the authority to take action to reduce risks associated with certain PBT chemicals. This may include regulations to limit or phase out the production, processing, distribution, use, or disposal of these chemicals, as well as other risk management measures.

Why Does Complying With TSCA 6(h) Matter?

Section 6 of the TSCA grants the EPA authority to take specific actions to address risks posed by PBT chemicals. Such actions may include requiring testing, imposing restrictions or bans on manufacturing or processing, or implementing other risk management measures to mitigate their adverse impacts. PBTs are of particular concern because they can persist in the environment for long periods, accumulate in the food chain, and potentially cause harm to human health and ecosystems. Some of the known adverse health effects of PBT chemicals include reproductive and developmental problems, neurological disorders, and other negative impacts on systemic organs including the liver, heart, and lungs. Because of these harmful effects, regulating these substances under TSCA section 6(h) is essential for protecting public health and the environment.

Who Does TSCA 6(h) Apply To?

TSCA Section 6(h) applies to various U.S. market stakeholders involved in the manufacturing, processing, distribution, use, and disposal of PBT chemicals. This includes businesses and other entities engaging in various applications of the substances, such as industrial processes, consumer products, or other uses.Specifically, businesses may be affected by this regulation if they manufacture (including import), process, distribute in commerce, or use any of the PBT substances or products containing listed PBT substances, especially in plastics used in consumer electronics.

Who Enforces TSCA 6(h)?

The EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) oversees TSCA programs related to the regulation of chemical substances, including PBT chemicals. This office is responsible for conducting risk assessments, issuing orders, monitoring compliance, and enforcing TSCA provisions to protect human health and the environment from chemical risks. Enforcement actions can include audits/investigations, compliance monitoring, and issuing of orders or penalties for non-compliance. 

In addition to federal enforcement efforts, state environmental agencies may also have a role in enforcing TSCA regulations within their jurisdictions, particularly in areas where states have delegated authority to implement and enforce certain aspects of TSCA programs. Post-market surveillance agencies may also monitor compliance and report noncompliance events to the EPA as the primary enforcement authority for TSCA regulations at the national level.

What’s the Timeline for Compliance With TSCA 6(h)?

TSCA Section 6(h) assumes default compliance immediately upon placing a product on the market. In 2021, the restriction for four PBT chemicals listed under TSCA Section 6(h) came into effect and remain in effect today:

• Decabromodiphenyl ether (DecaBDE) (CAS 1163-19-5)
• 2,4,6-tris(tert-butyl)phenol (2,4,6 TTBP) (CAS 732-26-3)
• Hexachlorobutadiene (HCBD) (CAS 87-68-3)
• Pentachlorothiophenol (PCTP) (CAS 133-49-3)

However, the EPA has given until October 31, 2024, to comply with a prohibition on the processing and distribution of articles for the fifth substance:

• Phenol, isopropylated phosphate (3:1) or PIP 3:1 (CAS 68937-41-7)

The EPA has the authority and responsibility to add more PBTs to the list through either restrictions or bans. There are thousands of substances that fall into the category of PBTs, most notably PFAS; as a result, it’s important to continue monitoring all regulations, including TSCA, for relevant updates.

What Must Manufacturers Do to Comply?

Manufacturers may need to reformulate their products to eliminate or reduce the presence of PBT chemicals to comply with the regulatory requirements. This could involve substituting PBT chemicals with safer alternatives or redesigning products to minimize their environmental and health impacts. Companies sourcing materials or components from suppliers must also ensure compliance with TSCA regulations regarding PBT chemicals. This involves conducting due diligence on the chemical content of materials and requiring suppliers to provide assurances of compliance.

TSCA Section 6(h) regulations regarding PBT chemicals can shape product development, manufacturing practices, supply chain management, marketing strategies, and consumer relations across various industries. Compliance with these regulations is essential for ensuring the safety and sustainability of products and maintaining regulatory compliance and market competitiveness.