Introduced in the Senate in March 1976 and signed into law in October of the same year, the Toxic Substances Control Act (TSCA) today still regulates commerce and use restrictions on substances/chemicals that may pose an unreasonable risk to human health or to the environment.
In this article, our experts address the most common questions regarding the Act and what it implies for businesses to be compliant.
TSCA FAQs Answered
Scope Of The Act: EPA Administration & Substances Management
Q: What Is The Purpose Of TSCA?
A: The Act’s objective is to assess and regulate existing chemicals present on the US market as well as new substances before they enter the country. It comprises six titles each with its specific regulations:
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- 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 administers the Act. The agency has authority to:
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- Request information from manufacturers and processors, chemical risks profiles specifically
- 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
Q: Are There Exceptions To The List Of Regulated Substances?
A: Substances not within the scope of TSCA are those administered by other federal agencies:
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- Food, drugs, medical devices, and cosmetic which fall under the FDA mandate
- Pesticides which are regulated by the Federal Insecticide and Rodenticide Act
- Tobacco and related products which are regulated by the Bureau of Alcohol, Tobacco, Firearms, and Explosives
- Radioactive materials and radioactive waste are administered by the Nuclear Regulatory Commission
Substances used in small amounts for the purpose of research and development may also be exempt from TSCA regulation.
Q: How Does The EPA Manage The Substances In Scope?
A: The EPA has been maintaining the TSCA inventory since 1977, to date a list of 86,000 chemicals manufactured or processed in the US. New chemicals (any chemical currently not on the list) may be added after manufacturers or processors have submitted a premanufacture notice (PFM) and a notice of commencement (NOC). The EPA also maintains an inventory of confidential substances only the Agency can access.
Organizations Impacted & Requirements
Q: Who Is Subject To Comply With TSCA?
A: Entities or persons that manufacture, process, distribute, uses, and/or disposes of chemicals are required to comply:
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- Corporations
- Associations
- States and municipalities
- Federal agencies and departments
- Individuals
Q: What Are The Requirements Of The Duty Holders For Existing Chemicals?
A: Compliance is regulated under the Inventory Update Rule (IUR). It stipulates companies must report substances listed on the TSCA inventory every five years when the volume reaches 25,000 lbs. annually. Reporting shall include:
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- Production volume
- Plant site
- Site-limited status of the chemicals
- Data on inorganic chemicals
- Number of workers exposed
- List of uses
If the volume is above 300,000 lbs., companies must provide additional processing information and use data.
Importers are required to certify each shipment complies with TSCA (in form of positive certification) or that imported substances are not subject to the rules of the Act (negative certification).
Q: What Are The Requirements For New Substances?
A: The EPA considers “new” a substance that is not listed on the TSCA inventory, whether it already exists or is indeed a newly developed chemical.
As manufacturer or importer, you have 90 days to notify the Agency of your intent to produce or source new chemicals.
An existing chemical may also be designated as new if “significant new use” occurs that could have an extended impact on human health or the environment. Factors of toxicity typically address risks of cancer and neurological effects, impairment due to exposure, damage to the biotope and ecosystems, and potential water contamination.
Implementation & Enforcement
Q: Is TSCA Only Enforced At The Federal Level?
A: The Federal Government is the major actor in implementing TSCA, though States have the discretion to deploy EPA-approved programs for some parts of the statute. They may, for instance, develop additional accreditation and certification labels and supplement standards they deem insufficient in terms of risk assessment and abatement.
Q: Are There Penalties For Non-Compliance?
A: The law provides the EPA with authority to bring criminal charges onto non-compliant companies, that is companies that “knowingly or willfully” violate the rules. Fines can amount up to $32,500 per day of violation. Imprisonment can be for up to a year. Criminal penalties do not exclude the possibility of civil penalties.
Making TSCA Compliance Easy
Q: What Is The Best Approach To Reach TSCA Compliance?
A: Like most of the compliance programs devised by state agencies and governments, the two most important factors are:
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- Quality of the data
- Accuracy of supplier documentation
Whether you need help with gathering documents from your suppliers or your subsidiaries, a centralized system like Source Intelligence’s platform is the best approach for TSCA compliance. Automation allows you to submit timely notifications and get real-time compliance status updates.
It’s up to you to manually compare the list of chemicals you manufacture, import, or distribute against the 86,000 line-long inventory (think pages, rather), or you can let Source Intelligence’s AI-powered compliance software run it for you.
Regulation against harmful chemicals is only going to tighten over the next few years, especially given the climate and environment protection agenda. We propose to take care of the manual work so you can focus on developing new products, opening new markets, and satisfying more and more customers.
Book a demo of our TSCA compliance solution today to see what it can do for you.
