A Guide to the Toxic Substances Control Act Requirements, Process, and Compliance

The Toxic Substances Control Act (TSCA) plays a critical role in protecting human health and the environment from the potential risks posed by chemical substances and mixtures. This comprehensive guide provides a deep dive into the key aspects of TSCA, enabling readers to understand the complex regulatory landscape, comply with mandatory requirements, and effectively manage chemical risks. By exploring the Act's history, jurisdiction, compliance standards, and enforcement mechanisms, readers will gain the knowledge necessary to navigate TSCA's provisions confidently. The guide also highlights recent amendments and regulatory changes, ensuring that readers stay informed about the evolving nature of chemical regulation in the United States. With an emphasis on practical guidance and real-world examples, this resource empowers readers to proactively address chemical safety concerns and contribute to a safer, more sustainable future.

GENERAL INFORMATION

Key Details of the Toxic Substances Control Act

Issuing Agency: Environmental Protection Agency
Year Established: 1976
Last Amended: 2016 (Frank R. Lautenberg Chemical Safety for the 21st Century Act)
Statutory Authority: Toxic Substances Control Act
Primary Legal Reference: Title 15, Chapter 53 of the United States Code

What is the Toxic Substances Control Act?

The Toxic Substances Control Act (TSCA) is a federal law that provides the Environmental Protection Agency (EPA) with the authority to regulate the manufacture, processing, distribution, use, and disposal of chemical substances and mixtures in the United States.[^1] The law was enacted in 1976 in response to growing concerns about the potential risks posed by chemicals to human health and the environment.

Under TSCA, the EPA has several key responsibilities:

  1. Maintaining the TSCA Inventory, a list of all chemicals manufactured or processed in the U.S.[^2]
  2. Requiring pre-manufacture notices (PMNs) for new chemicals before they enter the market
  3. Requiring testing of chemicals that may pose a risk to human health or the environment
  4. Regulating the production, importation, use, and disposal of chemicals that pose an unreasonable risk

The Frank R. Lautenberg Chemical Safety for the 21st Century Act, passed in 2016, significantly amended TSCA to strengthen the EPA's authority to regulate chemicals, mandate the review of existing chemicals, and increase transparency in the chemical regulatory process.

TSCA applies to a wide range of chemical substances but excludes certain categories, such as pesticides, tobacco, nuclear materials, firearms, and food additives, which are regulated under other federal laws.[^4]

What does the Toxic Substances Control Act protect?

The Toxic Substances Control Act aims to protect human health and the environment from the potential risks associated with exposure to chemical substances and mixtures. The regulation seeks to prevent or minimize the release of harmful chemicals into the air, water, and soil, thereby safeguarding:

  • Public health: By regulating the manufacture, use, and disposal of potentially toxic chemicals, TSCA reduces the risk of human exposure through direct contact, inhalation, or ingestion of contaminated water, food, or air.
  • Environmental quality: TSCA helps protect air, water, and soil resources from chemical contamination that could harm wildlife, disrupt ecosystems, or degrade the environment's ability to support life.
  • Vulnerable populations: The regulation pays particular attention to the potential risks posed by chemicals to sensitive subgroups, such as children, the elderly, and those with pre-existing health conditions.

[^1]: 15 U.S.C. § 2601 et seq. [^2]: 15 U.S.C. § 2607(b) [^4]: 15 U.S.C. § 2602(2)(B)

REGULATORY SCOPE & JURISDICTION

Regulated Activities, Entities & Prohibited Substances

The Toxic Substances Control Act (TSCA) regulates a wide range of activities and entities involved in the manufacture, processing, distribution, use, and disposal of chemical substances and mixtures. The Act applies to various industries, including chemical manufacturers, processors, importers, and distributors, as well as downstream users of chemical substances, such as the automotive, electronics, and construction sectors.

Under TSCA, the following activities and substances are prohibited:

  1. Manufacturing, processing, or distributing in commerce any chemical substance that is not on the TSCA Inventory, unless it is subject to an exemption or exclusion 1.
  2. Manufacturing, processing, or distributing in commerce a chemical substance for a use that has been determined to present an unreasonable risk of injury to health or the environment 2.
  3. Failing to comply with significant new use rules (SNURs) for existing chemical substances 3.
  4. Manufacturing, processing, or distributing in commerce any chemical substance in violation of a Section 4 test rule, Section 5 order, or Section 6 rule or order 4.

These prohibitions aim to prevent the introduction of potentially harmful chemical substances into the environment and protect human health by ensuring that chemicals are adequately assessed and regulated based on their risks.

Key Sections of the Toxic Substances Control Act

Section 5 - New Chemical Substances

  • Purpose: To ensure that new chemical substances are adequately assessed for potential risks before being introduced into commerce.
  • Key requirements: Manufacturers, importers, and processors must submit a premanufacture notice (PMN) to the Environmental Protection Agency (EPA) at least 90 days before commencing the manufacture or import of a new chemical substance 5.
  • Significance: This section helps prevent the introduction of potentially harmful new chemicals into the environment and allows the EPA to assess and regulate new substances based on their risks.
  • Compliance strategies: Submitting complete and accurate PMNs, engaging in pre-submission consultations with the EPA, and staying informed about EPA's decisions and any associated requirements or restrictions.

Section 6 - Regulation of Hazardous Chemical Substances and Mixtures

  • Purpose: To grant the EPA authority to regulate existing chemical substances and mixtures that present an unreasonable risk of injury to the health or the environment.
  • Key requirements: The EPA can prohibit or limit the manufacture, processing, distribution, use, or disposal of a chemical substance or mixture if it determines that such activities present an unreasonable risk 6.
  • Significance: This section enables the EPA to take action against hazardous chemicals already in commerce, ensuring that they are used safely or phased out if necessary.
  • Compliance strategies: Staying informed about EPA's risk evaluations and regulations, complying with any restrictions or requirements imposed on specific chemical substances or mixtures, and considering alternative substances or processes when necessary.

Relationship to Other Regulations & Agencies

The Toxic Substances Control Act interacts with various other federal, state, and local regulations and agencies:

  1. The EPA is the primary federal agency responsible for implementing and enforcing TSCA. However, other federal agencies, such as the Occupational Safety and Health Administration (OSHA) and the Consumer Product Safety Commission (CPSC), also have roles in regulating chemicals in their respective jurisdictions.
  2. TSCA does not preempt state or local laws regulating chemical substances, unless they are in direct conflict with TSCA or an EPA action taken under TSCA 7.
  3. TSCA interfaces with other federal environmental laws, such as the Clean Air Act (CAA), Clean Water Act (CWA), and Resource Conservation and Recovery Act (RCRA).

Developers, environmental consultants, and other stakeholders must be aware of the interplay between TSCA and other regulations and agencies to ensure comprehensive compliance and effectively navigate the regulatory landscape.

COMPLIANCE REQUIREMENTS & STANDARDS

Regulatory Standards & Limitations

The Toxic Substances Control Act (TSCA) and its implementing regulations establish various standards and limitations to control the manufacture, processing, distribution, use, and disposal of chemical substances that may pose risks to human health or the environment.[^200] These standards may include:

  • Emissions limits: Restrictions on the quantity or concentration of a chemical substance that may be released into the air, water, or soil during manufacturing, processing, or use.[^201]
  • Performance standards: Requirements for the design, operation, or maintenance of equipment or processes to minimize the release of toxic substances.[^202]
  • Product content standards: Limitations on the concentration of certain chemicals in consumer inspiredproducts or[industrial materials.[^203]

The Environmental Protection Agency (EPA) is responsible for implementing and enforcing these standards through a variety of mechanisms, such as:

  • Pre-manufacture review: Requiring manufacturers to submit information on new chemical substances before they are produced or imported, allowing the EPA to assess potential risks and impose necessary controls.[^204]
  • Risk evaluation: Conducting assessments of the hazards and exposure pathways of existing chemicals to determine if they present unreasonable risks and warrant regulation.[^205]
  • Significant new use rules (SNURs): Requiring notification and review of any new uses of a chemical substance that the EPA determines may result in significant changes to human or environmental exposures.[^206]

Monitoring, Reporting & Recordkeeping Obligations

Entities subject to TSCA are required to maintain records and submit reports to the EPA to demonstrate compliance and provide information on the production, use, and disposal of regulated chemical substances.[^207] These obligations may include:

  • Chemical Data Reporting (CDR): Manufacturers and importers of certain chemical substances must submit periodic reports on the identity, quantity, and uses of these substances.[^208]
  • Substantial Risk Notifications: Companies must immediately inform the EPA if they obtain information suggesting that a chemical substance presents a substantial risk of injury to health or the environment.[^209]
  • Recordkeeping: Entities must maintain records of the manufacture, processing, distribution, use, and disposal of regulated substances, as well as any data related to their health and environmental effects.[^210]

The monitoring, reporting, and recordkeeping requirements serve critical functions in ensuring compliance with TSCA standards and providing the EPA with the information necessary to assess and manage chemical risks.

Enforcement Actions & Penalties

The EPA conducts inspections and audits to monitor compliance with TSCA requirements. These may include:

Inspection TypeFrequencyScope
RoutinePeriodicGeneral compliance check
TargetedAs neededFocused on specific issues or high-risk facilities
Complaint-drivenReactiveInitiated in response to citizen complaints or tips

During inspections, regulated entities have the right to be informed of the purpose and legal authority for the inspection, and to have an authorized representative present. They also have the responsibility to provide access to records and facilities, and to cooperate with inspectors.[^212]

Violations of TSCa can result in various penalties, depending on the nature and severity of the offense:

Penalty TypeExamples of ViolationsFactors Affecting Severity
Administrative- Recordkeeping failures- Reporting omissions- History of violations- Extent of harm or risk
Civil- Failure to comply with orders- Knowing violations- Duration of violation- Economic benefit of noncompliance
Criminal- Willful violations- Tampering with monitoring equipment- Intent- Endangerment to human life

The maximum penalties for TSCA violations can include fines of up to $37,500 per day for civil violations and up to $50,000 per day and/or imprisonment for criminal offenses.[^213]

Compliance Assistance & Regulatory Incentives

The EPA offers various programs and resources to assist entities in understanding and complying with TSCA:

  • Compliance Assistance Centers: The EPA sponsors industry-specific centers that provide tools, training, and support to help businesses achieve and maintain compliance.[^214]
  • Guidance Documents: The agency publishes guidance on interpreting and applying TSCA requirements.[^215]
  • Workshops and Webinars: The EPA hosts regular events to educate stakeholders on TSCA requirements and best practices.[^216]

In addition, the EPA offers incentives to encourage the development and adoption of safer chemical alternatives:

  • Safer Choice Program: Products containing chemical ingredients that meet stringent safety criteria are eligible for the Safer Choice label, which helps consumers and businesses identify safer products.[^217]

Entities interested in these assistance and incentive programs should visit the EPA's TSCa website (https://www.epa.gov/chemicals-under-tsca) for more information and contact details.

[^200]: 15 U.S.C. § 2601 et seq. [^201]: 40 C.F.R. § 63.1103 [^202]: 40 C.F.R. § 63.1107 [^203]: 15 U.S.C. § 2604(a)(2) [^204]: 15 U.S.C. § 2604 [^205]: 15 U.S.C. § 2605(b) [^206]: 40 C.F.R. § 721 [^207]: 15 U.S.C. § 2607 [^208]: 40 C.F.R. Part 711 [^209]: 15 U.S.C. § 2607(e) [^210]: 40 C.F.R. § 704 [^212]: "TSCA Inspections." EPA. Accessed April 13, 2023. [^213]: 15 U.S.C. § 2615 [^214]: "Compliance Assistance Centers." EPA. Accessed April 13, 2023. https://www.epa.gov/compliance/compliance-assistance-centers [^215]: "Toxic Substances Control Act Compliance Monitoring Strategy." EPA. Accessed April 13, 2023. [^216]: "Webinars and Training." EPA. Accessed April 13, 2023. [^217]: "Safer Choice." EPA. Accessed April 13, 2023. https://www.epa.gov/saferchoice

ADDITIONAL RESOURCES

Regulatory History & Upcoming Changes

The Toxic Substances Control Act (TSCA) was originally enacted in 1976 to regulate the manufacture, importation, processing, distribution, use, and disposal of certain chemical substances and mixtures[^300]. The law aimed to protect human health and the environment from unreasonable risks posed by chemicals[^301].

In 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law, significantly amending TSCA[^302]. The amendments were driven by concerns that the original law was outdated and ineffective in regulating the safety of chemicals. Key provisions of the 2014 amendments include[^304]:

  1. Requiring EPA to evaluate the safety of existing chemicals with clear and enforceable deadlines
  2. Providing EPA with new risk assessment and risk management tools
  3. Increasing public transparency for chemical information
  4. Establishing a new safety standard of "unreasonable risk"

The amended TSCA requires EPA to prioritize and evaluate the risks of chemicals already in commerce, starting with those most likely to cause harm. As of 2023, EPA has identified several high-priority substances for risk evaluation, including asbestos, 1,4-dioxane, and certain phthalates.

Regulated entities should stay informed about ongoing risk evaluations and any proposed rules or regulatory changes related to TSCA by:

  • Regularly checking EPA's TSCA website for updates[^307]
  • Subscribing to EPA's email alerts and newsletters[^308]
  • Engaging with industry associations and attending relevant conferences or webinars
  • Monitoring the Federal Register for proposed rules and public comment opportunities[^309]

Additional Resources

[^300]: 15 U.S.C. § 2601 et seq. [^301]: U.S. Environmental Protection Agency. (2021, April 13). Summary of the Toxic Substances Control Act. https://www.epa.gov/laws-regulations/summary-toxic-substances-control-act [^302]: Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. No. 114-182, 130 Stat. 448 (2016). [^304]: U.S. Environmental Protection Agency. (2016, June 22). The Frank R. Lautenberg Chemical Safety for the 21st Century Act: First year implementation plan. [^307]: https://www.epa.gov/chemicals-under-tsca [^308]: https://public.govdelivery.com/accounts/USAEPATRI/subscriber/new [^309]: https://www.federalregister.gov/ [^310]: https://www.epa.gov/laws-regulations/summary-toxic-substances-control-act [^311]: https://www.epa.gov/chemicals-under-tsca [^312]: https://www.epa.gov/tsca-inventory [^313]: Bergeson, L. L. (2018). The Toxic Substances Control Act: A practical guide. American Bar Association.

REFERENCES

  1. 15 U.S.C. § 2604(a)(1)(A)

  2. 15 U.S.C. § 2605(a)

  3. 40 C.F.R. § 721.25

  4. 15 U.S.C. § 2614(1)

  5. 15 U.S.C. § 2604(a)(1)

  6. 15 U.S.C. § 2605(a)

  7. 15 U.S.C. § 2617

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A Note to Our Readers: We hope this guide is a valuable resource in helping you better understand the TSCA. However, it's not a substitute for professional advice and doesn't cover every scenario. Always consult with regulatory bodies and professionals for the most current advice and project-specific guidance.