What is the Toxic Substances Control Act (TSCA)?

The Extensive History of the TSCA

The Toxic Substances Control Act (TSCA) was enacted in 1976 to address the risks posed by hazardous chemicals to human health and the environment in the United States.

It was the first federal law that gave the Environmental Protection Agency (EPA) the authority to regulate industrial chemicals before they entered the market, marking a significant step toward chemical safety and environmental protection.

This law has had two monumental milestones throughout history, shaping it to fit the modern threats we’re currently facing.

Passage of TSCA in 1976

On October 11, 1976, the 94th United States Congress passed a law in response to growing concerns about the potential dangers of industrial chemicals, which were often released into the environment without adequate testing or regulation.

The TSCA granted the EPA the power to require testing of chemicals that posed an “unreasonable risk” to health or the environment.

The law targeted three main areas:

• Pre-market Review: The EPA could require testing new chemicals before being introduced to the market.
• Testing Existing Chemicals: For chemicals already in commerce, the EPA had limited authority to require testing, which left many potentially hazardous substances unregulated.
• Restricting or Banning Chemicals: If the EPA identified a chemical as posing an unreasonable risk, it could restrict or ban its use.

Although TSCA was groundbreaking, it soon became clear that the law had significant limitations.

The EPA faced substantial challenges in enforcing regulations due to insufficient resources and legal restrictions.

2016 Amendments: The Frank R. Lautenberg Chemical Safety for the 21st Century Act

Recognizing the limitations of the original TSCA, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22, 2016 — the most comprehensive and significant update to TSCA since its inception.

The Lautenberg Act aimed to address the original law’s deficiencies and strengthen the EPA’s ability to regulate new and existing chemicals effectively:

• Mandatory Evaluation of Chemicals: The EPA is now required to evaluate existing chemicals with clear deadlines, prioritizing those most likely to pose health or environmental risks.
• Increased Transparency and Access to Data: The amendments required chemical companies to disclose health and safety information while protecting certain confidential business information.
• Mandatory Safety Review of New Chemicals: The EPA must now review and determine any new chemical or significant new use of an existing chemical before it enters the market.

The 2016 amendments represented a significant shift in U.S. chemical policy, with the EPA now actively engaged in evaluating thousands of chemicals.

The new risk-based standard allowed the agency to focus on protecting vulnerable populations, such as children and workers, and prioritize chemicals with high exposure risks.

The Role of the TSCA

The TSCA plays a crucial role in regulating chemical substances and protecting public health and the environment from potential risks.

Critical roles the TSCA fulfills in regulating chemicals within each stage of this lifecycle include:

• Regulating the Introduction of New Chemicals: The TSCA mandates that the EPA review any new chemical substance or significant new use of an existing chemical before it is manufactured or brought to market. This thorough pre-market review process ensures new chemicals entering the market have been assessed for potential health and environmental risks.
• Monitoring and Regulating the Manufacture and Use of Existing Chemicals: The EPA is tasked with identifying and prioritizing chemicals for risk evaluation based on potential health and environmental concerns. High-priority chemicals undergo detailed risk assessments to determine their impact on humans and the environment.
• Ensuring Safe Disposal of Hazardous Chemicals: The TSCA also provides guidelines for the safe disposal of chemical substances, particularly those that are persistent, bioaccumulative, or toxic. These regulations are critical for preventing soil, water, and air contamination, reducing exposure to toxic chemicals, and mitigating public health risks.
• Encouraging Transparency and Data Collection: Under the TSCA, the EPA can require manufacturers to conduct tests and submit data on a chemical’s safety profile, properties, and potential risks. This data transparency enables the EPA to make informed regulatory decisions based on scientific evidence.
• Promoting Safer Chemicals and Alternatives: TSCA amendments, particularly the 2016 Lautenberg Act, encourage innovation in safer chemicals and alternatives. When certain chemicals are identified as posing high risks, the TSCA empowers the EPA to restrict their use, prompting manufacturers to develop safer alternatives.

Its authority to regulate the introduction, manufacture, use, and disposal of chemicals allows the EPA to proactively address potential health and environmental hazards.

While challenges remain, the TSCA’s framework and ongoing reforms provide a critical regulatory foundation for chemical safety in the United States, helping to protect communities and ecosystems from the risks posed by hazardous chemicals.

What Chemicals Are Regulated Under the TSCA?

The Toxic Substances Control Act (TSCA) Chemical Substance Inventory contains all chemicals and substances the EPA tagged as a health and environmental risk.

Categories of chemicals and substances the EPA regulates include:

• Industrial chemicals
• Persistent, bioaccumlative, and toxic (PBT) chemicals
• Polychlorinated biphenyls (PCBs)
• Asbestos
• Nanomaterials

Industrial Chemicals

Industrial chemicals are substances used in manufacturing, construction, electronics, textiles, and other industries.

This category is a major focus of TSCA. These chemicals are widely used in various sectors, often in large quantities, which increases the potential for exposure to humans and the environment.

TSCA regulations target industrial chemicals with broad applications.

It also looks at the present health risks such as carcinogenicity, neurotoxicity, reproductive toxicity, or organ toxicity.

The regulation also mitigates the use of hazardous chemicals like polychlorinated biphenyls (PCBs) and certain flame retardants.

Persistent, Bioaccumulative, and Toxic (PBT) Chemicals

PBT chemicals are among the most dangerous substances regulated under TSCA due to their unique properties.

These chemicals do not easily break down in the environment, which means they can remain active and hazardous over long periods.

PBT chemicals also accumulate in the tissues of living organisms, concentrating as they move up the food chain, which can lead to serious ecological and health impacts.

Common examples of PBTs include:

• Mercury compounds
• Phthalates
• Polychlorinated biphenyls (PCBs)
• Brominated flame retardants

Polychlorinated Biphenyls (PCBs)

Polychlorinated biphenyls (PCBs) were used extensively in electrical equipment, hydraulic systems, and other industrial applications until they were found to have catastrophic health and environmental impacts.

PCBs accumulate in the tissues of animals and humans, concentrating as they move up the food chain.

Constant exposure to PCBs has been linked to cancer, immune system suppression, and reproductive and developmental problems.

Asbestos

Asbestos is a mineral naturally found in nature. Because of its beneficial properties, manufacturers once used it in construction materials, insulation, and automotive parts.

Exposure to asbestos can cause serious health problems, such as asbestosis, mesothelioma, and lung cancer.

Although the EPA attempted to ban asbestos entirely under TSCA in 1989, the courts only partially upheld the ban.

In 2019, the EPA issued new regulations requiring manufacturers to notify the agency before reintroducing asbestos into new products.

Nanomaterials

As industries increasingly turn to nanotechnology, the TSCA also covers nanomaterials, which are materials engineered at the atomic or molecular scale.

Nanomaterials are used in various applications, including electronics, healthcare, and consumer products.

Due to their unique properties, nanomaterials may interact with biological systems in ways that larger particles do not, potentially causing unforeseen health and environmental effects.

Some nanomaterials may not degrade easily in the environment, raising concerns about long-term exposure.

The Environmental Protection Agency (EPA): The Overseer of the TSCA

The EPA’s process includes assessing novel and current chemicals to protect human health and the environment from potential risks.

With the TSCA in effect, the EPA’s approach to enforcement and evaluation includes detailed steps for reviewing, listing, and regulating chemicals and managing potential exposure risks.

New Chemical Evaluation Process

For chemicals that are new to the market, the TSCA mandates a pre-manufacture notification to the EPA.

Manufacturers must submit detailed information about a new chemical, including:

• Chemical identity and structure
• Intended uses and applications
• Possible environmental releases
• Available health and safety data

The EPA then reviews the PMN within 90 days and assesses the potential risks to human health and the environment.

If the EPA finds that the new chemical may pose a significant risk, it can:

• Issue restrictions or conditions on its production or use
• Request additional testing data
• Require the company to adopt specific handling or labeling practices
• In extreme cases, the EPA can halt the manufacture or distribution of the new chemical

Evaluation of Existing Chemicals

The EPA is also tasked with evaluating chemicals already on the market before TSCA’s 1976 enactment, as well as any others introduced since then.

To prioritize these existing chemicals, the 2016 TSCA amendments (under the Frank R. Lautenberg Chemical Safety for the 21st Century Act) established a systematic framework for reviewing chemicals in three main stages.

The systematic framework includes:

• The EPA selects high-priority chemicals for evaluation based on criteria such as toxicity, exposure potential, and persistence in the environment. Chemicals that have the potential for widespread exposure or significant health impacts are prioritized.
• For chemicals that reach the risk evaluation phase, the EPA conducts a detailed assessment of the chemical’s toxicity, risk of exposure, and long-term effects of frequent exposure.
• If a chemical is determined to pose an unreasonable risk, the EPA moves to restrict its use, which can include bans, phase-outs, labeling requirements, or disposal restrictions. The agency must implement these risk management actions within two years of completing the risk evaluation.

Listing and Regulating Toxic Chemicals

Under TSCA, certain chemicals are identified and regulated more stringently due to their toxicity.

These substances are listed and updated in the TSCA chemical substance inventory, which also defines their regulatory statuses.

Chemicals are designated as either active or inactive. Active chemicals are substances regularly used commercially or industrially.

Chemicals deemed hazardous may be restricted or flagged as needing further testing or monitoring.

Conversely, inactive chemicals are those with current restrictions.

Managing Exposure Risks

TSCA enforcement focuses heavily on mitigating exposure risks associated with hazardous chemicals.

The EPA takes various approaches to limit the potential harm from toxic substances, including:

• Worker and Consumer Protection: For chemicals used in manufacturing, the EPA imposes safety requirements to protect at-risk workers.
• Environmental Exposure Limits: The EPA sets exposure limits for chemicals that could enter the environment, regulating their release into air, water, or soil.
• Public Health Monitoring and Education: The EPA monitors public health impacts of certain chemicals, such as lead, asbestos, and PCBs, and works to educate the public on safe handling and disposal methods.
• Disposal and Remediation: For highly hazardous substances, TSCA allows the EPA to set strict disposal regulations to prevent contamination. The EPA can mandate remediation efforts to clean up polluted sites in cases of existing contamination.

Enforcement Mechanisms

The EPA conducts routine inspections of facilities that manufacture, process, or dispose of these noxious chemicals.

Inspections ensure compliance with TSCA standards, such as proper labeling, storage, and disposal.

If companies violate TSCA regulations, the EPA can impose fines, mandate corrective actions, or take legal action.

Penalties serve as a deterrent to ensure compliance with TSCA standards.

The EPA is authorized to publicize risk evaluations and safety information, promoting transparency and allowing communities to make informed decisions regarding chemical risks.

The EPA can also require manufacturers to test chemicals suspected of posing health or environmental risks.

Testing data helps the agency make informed decisions on necessary regulations and safeguards.

How the TSCA Will Affect Businesses and Consumers

Industries that handle or produce chemicals face unique risks, particularly to worker health and safety.

The TSCA imposes specific exposure limits for hazardous chemicals in workplace environments to reduce workers’ risk of developing chronic illnesses from prolonged exposure.

By setting standards for chemical handling, storage, and disposal, the TSCA helps industries implement safe practices that mitigate the risk of accidental exposure or spills.

Compliance with the TSCA often requires companies to educate workers on handling toxic chemicals safely.

Beyond worker protection, TSCA regulations also play a vital role in safeguarding consumers from exposure to toxic chemicals.

When industries adhere to TSCA requirements, they ensure that chemicals reaching the consumer market meet safety standards, reducing the likelihood of hazardous exposure through consumer products.

TorHoerman Law: Have You Been Exposed to Toxic Chemicals?

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