What is the Toxic Substances Control Act (TSCA)?

The Toxic Substances Control Act (TSCA) was first introduced in 1976, during the “environmental decade,” when the United States was facing pollution issues from the second American industrial revolution. TSCA, which is enforced by the Environmental Protection Agency (EPA), regulates new and existing chemical substances and/or mixtures in an attempt to reduce risk to public health or the environment. It also excludes substances regulated under other federal laws like food and drugs.

Which Chemicals Are Regulated by the TSCA?

When the act was passed, the EPA gained the ability to secure information on all new and existing chemical substances by requiring manufacturers and importers to notify the EPA before using new chemicals or new uses of existing chemicals. This information allowed the EPA to restrict or regulate the substances if necessary. Over time, the US Congress added further addendums to the original act. These addendums were labeled as "Titles." As of today, there are six TSCA Titles:

• Title I – Control of Toxic Substances
• Title II – Asbestos Hazard Emergency Response
• Title III – Indoor Radon Abatement
• Title IV – Lead Exposure Reduction
• Title V - Healthy High-Performance Schools
• Title VI - Formaldehyde Standards for Composite Wood Products

The EPA is authorized by the TSCA to gather critical information on chemical risks from chemical processors and manufacturers and requires companies to analyze and report chemicals and chemical mixtures for toxic effects. The EPA also has the authority to review most chemical mixtures before manufacturing begins and can prevent risks to public and environmental health by regulating the manufacturing of harmful substances.

Six chemical substances receive special attention under TSCA: PCBs, asbestos, radon, lead, mercury, and formaldehyde.

The Inclusion of TSCA Section 6(h)

In 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act gave TSCA Section 6(h) the ability to protect against persistent, bioaccumulative, and toxic (PBT) substances in articles. It currently covers these five substances:

1. PIP (3:1)
2. DecaBDE
3. PCTP
4. 2,4,6-TTBP
5. HCBD

These chemicals build up in the environment over time and can therefore have potential risks for exposed populations, including the general population, consumers and commercial users, and susceptible subpopulations. It’s important to note that there are MANY more PBTs (PBTs are on REACH & MDR lists as well), these are just the first 5 to be added. With the exception of PIP (3:1) which goes into effect in October of 2024, the rest went into effect in 2021. 

Which Chemicals Are Exempt From TSCA?

Generally, the following eight types of materials/chemicals are exempt from TSCA regulations: 

1. Pesticides
2. Tobacco
3. Specified nuclear material
4. Firearms and ammunition
5. Food
6. Food additives
7. Drugs
8. Cosmetics

While these may be exempt from TSCA, other Federal programs regulate many of these materials.

How the EPA Evaluates Existing Chemicals Under the TSCA

The EPA is tasked with evaluating information on chemicals to determine if a risk to human or environmental health exists. Toxic substances that do pose such risks can be banned or restricted by the EPA.

First, a chemical is designated as either a high-priority or low-priority risk for evaluation purposes. Substances designated as low-priority do not warrant further risk evaluation at that time.

The second step in the evaluation process is the actual risk evaluation of a substance. The EPA will evaluate the substance with the following methods:

• a scope document that provides the public with information on the focus of the risk evaluation
• hazard and exposure assessments and a risk characterization to inform the risk determination
• a risk determination stating whether or not a chemical substance presents an unreasonable risk to health or the environment under its conditions of use

The third and final step of the evaluation process is risk management, in which the EPA imposes restrictions under the authority of TSCA in order to eliminate a substance's unreasonable risk to the public and/or the environment. A range of risk management options are used under TSCA and include the following:

• Labeling
• Recordkeeping
• Notice requirements
• Actions to reduce human or environmental exposure
• Ban of the chemical
• Or ban of certain uses

TSCA Section 8: A New Focus on PFAS

Section 8 of the Toxic Substances Control Act (TSCA) is focused on information gathering, monitoring, and reporting requirements regarding chemical substances and mixtures. This section grants the Environmental Protection Agency (EPA) the authority to require manufacturers, processors, and distributors of chemical substances to keep records and submit reports that can assist in determining the impact of these substances on health or the environment. A current call for information is currently in place under Section 8(a)(7) for PFAS.

An extensive inventory of all chemicals manufactured, processed or imported in the United States can be downloaded from the EPA's website, here.

Federal Facility Compliance With TSCA

Federal facilities operations typically involve the management of toxic substances regulated under TSCA and, unlike with other regulations, are not exempt from TSCA. Facilities with older electric equipment like capacitors, fluorescent ballasts, and transformers often contain chemicals like PCBs, which are regulated under TSCA. These facilities must adhere to TSCA requirements to promote safe chemical management practices.

Under TSCA, federal facilities have varying requirements ranging from basic reporting and recordkeeping to specific asbestos, lead, and radon requirements.