The Toxic Substances Control Act (TSCA) requires companies to track, report, and manage chemical substances that may pose risks to human health or the environment. Manufacturers, importers, and other regulated entities must ensure compliance across the chemical lifecycle—from production and importation to use and disposal.
As TSCA requirements evolve—especially with new mandates like PFAS reporting under Section 8(a)(7)—businesses face increasing pressure to maintain accurate data and meet EPA expectations.
What is TSCA?
TSCA, enacted in 1976, empowers the U.S. Environmental Protection Agency (EPA) to regulate the manufacture, use, and distribution of chemical substances that may pose an unreasonable risk to human health or the environment. Under TSCA, the EPA can impose reporting obligations, testing requirements, and restrictions on both new and existing chemicals in commerce.
Since 1977, the EPA has maintained the TSCA Inventory, which lists approximately 86,000 chemicals manufactured or processed in the United States. New chemicals are added after manufacturers or processors submit a Pre-Manufacture Notice (PMN) and a subsequent Notice of Commencement (NOC).
TSCA’s primary purpose is to assess and regulate chemicals before they enter the U.S. market. The act is organized into six titles, each addressing specific regulatory requirements:
- 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
Requirements for new substances
Any chemical not listed on the TSCA Inventory is considered a new chemical substance. An existing chemical may also be considered new if a “significant new use” could impact human health or the environment.
It is critical to determine whether a chemical is on the Inventory before manufacturing or importing it. Section 5 of TSCA requires manufacturers of new chemical substances for non-exempt commercial purposes to submit a Pre-Manufacture Notice (PMN) to the EPA at least 90 days before production begins.
The TSCA Chemical Data Reporting Rule
The TSCA Chemical Data Reporting Rule (CDR) requires manufacturers and importers to report the production and use of chemicals in commerce to the EPA. Under this rule, the EPA collects information on the types, quantities, and uses of chemical substances that are either produced or imported into the U.S. If production volumes for a chemical are equal to or greater than 25,000 lbs. in a reporting year, manufacturers and importers must provide information every four years.
Regulatory powers granted to the EPA under TSCA
The EPA administers TSCA and has the authority to:
- Request information from manufacturers and processors, including chemical risks profiles
- Require testing to assess chemical toxicity
- Review new chemicals before they are manufactured
- Exercise preventive measures, such as requiring hazard warning labels
- Restrict or ban the production, processing, use, disposal, or distribution of certain chemical substances or mixtures
Entities and individuals subject to TSCA compliance
Entities and individuals that manufacture, process, distribute, use, or dispose of chemicals are required to comply with TSCA. These include:
- Corporations
- Associations
- States and municipalities
- Federal agencies and departments
- Private individuals
TSCA exemptions
Substances administered by other federal agencies are not within the scope of TSCA, including:
- Food, drugs, medical devices, and cosmetics - Food and Drug Administration (FDA)
- Pesticides - Federal Insecticide and Rodenticide Act (FIFRA)Tobacco and related products - Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF)
- Radioactive materials and radioactive waste - Nuclear Regulatory Commission (NRC)
Substances used in small amounts for the purpose of research and development may also be exempt from TSCA reporting requirements.
TSCA Section 8(a)(7) and PFAS reporting
Section 8(a)(7) of TSCA mandates comprehensive reporting of per- and polyfluoroalkyl substances (PFAS) to the EPA. This rule requires manufacturers, including importers, to disclose detailed information on PFAS uses, production volumes, disposal practices, exposures, and hazards. It applies retroactively to activities dating back to January 1, 2011, and encompasses both ongoing and historical data collection.
The importance of TSCA 8(a)(7) lies in its role in strengthening the EPA’s ability to evaluate PFAS risks and inform future regulatory decisions. By increasing transparency and accountability across industries, the rule supports a broader federal effort to address the environmental and public health impacts associated with PFAS, often referred to as “forever chemicals” due to their persistence in the environment.
For more information, check out our blog answering frequently asked questions about TSCA section 8(a)(7).
TSCA enforcement
The federal government primarily oversees TSCA regulatory authority and program implementation. However, states can receive authorization from the EPA to operate their own programs for certain parts of the statute. TSCA Title IV also allows states to develop additional accreditation and certification programs, as well as standard work practices for lead-related inspection, risk assessment, renovation, and abatement—provided they are at least as protective as existing EPA standards.
Penalties for TSCA non-compliance
TSCA empowers the EPA to criminally charge companies that “knowingly or willfully” violate its regulations. Depending on the criminal provision, individuals may face penalties ranging from a $50,000 fine per day and up to one year in prison, to fines of up to $250,000 and 15 years in prison. Corporations may face fines of up to $1,000,000 per violation.
How Source Intelligence supports TSCA compliance
Managing TSCA compliance is a significant challenge for companies with complex global supply chains. TSCA demands rigorous tracking, reporting, and risk mitigation across the manufacture, import, use, and disposal of chemical substances. Evolving regulations and growing data requirements make it increasingly difficult to maintain compliance at every operational level.
Source Intelligence’s TSCA compliance solution simplifies this process with an integrated platform that streamlines supplier engagement and automates data collection and validation. Our solution reduces manual workloads, improves data accuracy, and adapts to your evolving regulatory needs. Whether you need software-only tools or fully managed services, Source Intelligence delivers scalable, end-to-end support to keep your company compliant today—and ready for future regulatory changes.
