The Toxic Substances Control Act (TSCA), enacted in 1976, grants the Environmental Protection Agency (EPA) the authority to regulate commerce and use restrictions on chemicals that may pose an unreasonable risk to human health or the environment. We asked our team of experts some frequently asked questions related to TSCA and provided their answers below.
What is TSCA?
TSCA aims to assess and regulate new and existing chemicals in the U.S. market before they enter the country. The act consists of six titles, each with its own specific regulations:
- 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
Who administers TSCA?
The EPA administers TSCA. The agency has the authority to:
- Request information from manufacturers and processors, specifically chemical risks profiles
- Require testing to measure toxicity
- Review new chemicals before they are produced
- Exercise preventive authority such as requesting hazard warning labels
- Restrict or ban the production, processing, use, disposal, or distribution of certain chemical substances or combinations thereof
Which companies must comply with TSCA?
Entities or persons that manufacture, process, distribute, use, and/or dispose of chemicals must comply. This includes:
- Corporations
- Associations
- States and municipalities
- Federal agencies and departments
- Individuals
How does the EPA manage the regulated substances?
The EPA has maintained the TSCA Inventory since 1977, consisting of over 86,000 chemicals manufactured or processed in the U.S. New chemicals are added to the list after manufacturers or processors have submitted a pre-manufacture notice (PMN) and a notice of commencement (NOC).
Are there exceptions to the regulated substances list?
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 regulation.
What is 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.
What are the requirements for new substances?
Any chemical not on the Toxic Substances Control Act Inventory is considered a new chemical substance. An existing chemical can also be considered new if a “significant new use” of the chemical could impact human health or the environment.
Determining if a chemical is on the Inventory before manufacturing (and importing) a chemical substance is critical. Section 5 of TSCA requires manufacturers of new chemical substances for non-exempt commercial purposes to provide the EPA with a PMN at least 90 days in advance.
Is TSCA enforced at only the federal level?
The Federal Government primarily oversees TSCA regulatory authority and program implementation. However, States can receive the EPA's authorization to operate their programs for some parts of the statute. TSCA Title IV enables States to develop additional accreditation and certification programs and standard work for lead-related inspection, risk assessment, renovation, and abatement – as long as they are at least as protective as the existing standards set by the EPA.
What are the penalties for TSCA non-compliance?
TSCA enables the EPA to criminally charge non-compliant companies that “knowingly or willfully” violate TCSA regulations. Depending on the criminal provision, consequences for individuals range from a $50,000 fine per day and one year in prison to $250,000 in fines and 15 years in prison. Corporations face a maximum $1,000,00 fine per violation.
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