What is TSCA?
The Toxic Substances Control Act (TSCA) is a law that regulates the production, import, use, and disposal of chemicals in the U.S. It also controls the use of new and existing chemicals in the United States. The U.S. Environmental Protection Agency (EPA) implemented the Toxic Substances Control Act (TSCA) in 1976 to make sure that the effects of chemicals on human health and the environment are recognized and appropriately managed before their commercialization into the U.S. market. The main goal of the act is to provide information about all chemicals and to control the production of new chemicals that might present an unreasonable risk of injury to health or the environment. Understanding TSCA guidelines is important to ensure compliance and avoid US chemical import penalties.
EPA’s role in TSCA
The EPA’s role under TSCA is to study and regulate chemicals, keeping people and the environment safe. It checks the risks of new and existing chemicals and requires companies to report, test, or keep records. The EPA can limit or ban a chemical’s use if it is too dangerous. The agency also works to prevent pollution before it happens. To do this, the EPA uses scientific data, studies risks to vulnerable groups, and tracks chemicals with tools like the CompTox Chemicals Dashboard. It also hosts webinars to explain new rules and updates.
History
The TSCA Act was enacted on October 11, 1976, by Congress and signed into law by President Gerald Ford. It gives the power to the EPA to regulate new and existing chemicals to protect health and the environment. It limits the manufacture, use, and disposal of harmful substances like PCBs, asbestos, radon, and lead-based paint. After the TSCA Act came into effect, over 60,000 chemicals were tested, and some harmful ones, like asbestos, were banned under Section 6.
TSCA has been amended several times. Initially, it focused on regulating PCBs. In 1986 and 1990, it set asbestos standards for schools and contractor training. In 1988, warnings and restrictions on indoor radon were added, followed by lead prevention measures in 1992. The most significant update came in 2016 with the Lautenberg Act, signed by President Obama, which required the EPA to test and regulate chemicals more quickly. TSCA and its recent amendments have always received mixed reviews some arguing it burdens manufacturers, while others believe it lacks strict regulation.
Chemical Substance Inventory (TSCA Inventory)
The Toxic Substances Control Act (TSCA) Inventory is a comprehensive list of chemicals that help in the regulation of industrial chemicals in the United States. The inventory list has expanded significantly, now including over 86,000 chemical substances.
Chemicals listed on the TSCA Inventory are classified as “existing” substances in U.S. commerce. If any chemical is not on the Inventory, it is considered a “new chemical substance” and may require additional regulatory steps before use.
Chemicals that TSCA regulates
- Industrial chemicals (e.g., solvents, polymers, plastics)
- Inorganic chemicals (e.g., metals, minerals)
- Petrochemicals
- Surfactants and detergents
- Pesticide intermediates (not pesticides themselves)
- Chemical additives for industrial use
- New chemical substances
Chemicals that TSCA does not regulate
- FIFRA-regulated pesticides
- ATF regulates tobacco and tobacco products.
- NRC-regulated radioactive materials, FDA-regulated foods, food additives, medications, cosmetics, or equipment
- Research & Development (R&D) Chemicals
- Polymers (Under Certain Conditions)
- FDA Regulated substances under the Federal Food, Drug, and Cosmetic Act (FFDCA)
TSCA Rules for PFAS
PFAS (Per- and polyfluoroalkyl substances) are man-made chemicals used since the 1940s. Because they may harm health, the EPA created new rules in 2023 to check their safety. In October 2023, the EPA required companies that made or imported PFAS since 2011 to report how they use and dispose of them.
TSCA Rules for PCBs
PCBs (Polychlorinated biphenyls) were once used in electrical and industrial products but were banned in 1979 because they are toxic. TSCA rules apply to PCB waste and materials still in use, requiring proper labeling, storage, and disposal. Items with 50 ppm or more of PCBs must follow strict disposal rules.
TSCA Rules for Asbestos
TSCA and OSHA regulate asbestos use and removal. The Asbestos Hazard Emergency Response Act requires schools, hospitals, and public buildings to have management plans and safety rules when dealing with asbestos.
Things to keep in mind for TSCA compliance
1. Chemical Inventory Reporting
- Businesses must verify if chemicals are listed in the TSCA Chemical Regulation Act.
- If not listed, they must submit a Premanufacture Notice (PMN) before manufacturing or importing.
2. Risk Evaluation and Management
- The EPA assesses risks associated with new and existing chemicals.
- If a chemical is deemed high risk, businesses may be required to restrict usage or implement safety measures.
3. Recordkeeping and Reporting
- Companies must maintain chemical usage records, safety measures, and potential exposure risks.
- Periodic reporting to the EPA is necessary for high-priority substances.
4. Import and Export Regulations
- Importers must certify that chemicals comply with TSCA guidelines.
- Exporters may need to notify foreign entities about potential risks and comply with international agreements.
5. Significant New Use Rules (SNURs)
SNURs Regulations under the Toxic Substances Control Act (TSCA) section 5 (a) is issued by the U.S. Environmental Protection Agency (EPA) to require notification before certain chemicals are used in new ways that might pose risks to human health or the environment.
SNURs are submitted using the standard e-PMN form and reviewed within 90 days, like a PMN. The submission should include a cover letter that mentions the related SNUR regulation and describes the new use being proposed.
6. Chemical Data Reporting (CDR)
It is the rule under the TSCA to provide information to the EPA by the manufacturers and importers related to the production and commercial use of the chemical. It helps the EPA to collect basic exposure-related information like quantity, types, and use of chemicals. CDR collects the information at an interval of every 4 years from manufacturers and importers helping the EPA in risk assessment & evaluation, Screening, and risk management of chemicals.
The CDR regulation requires all companies to report data electronically with the help of e-CDRweb, the CDR web-based reporting tool, or by the Central Data Exchange (CDX) system of EPAs. Those individuals involved with completing the CDR Form U using e-CDRweb can register in CDX at any time.
Chemicals exempted from Chemical Data Reporting (CDR)
- Polymers: Most polymers are exempt from CDR due to their complex structure and variability depending on manufacturing processes.
- Food and drug-related chemicals: Chemicals regulated under the Food, Drug, and Cosmetic Act are typically exempt from CDR.
- Chemicals that are non-isolated intermediates created during manufacturing, or imported as part of an article like plastic parts with finished products and as impurities with other chemicals, or created as byproducts during manufacturing or reaction.
- Chemicals made or imported for non-TSCA purposes do not need to be reported. For example, pesticides are exempt from reporting under CDR by TSCA.
- Water and naturally occurring substances are usually exempt from CDR requirements.
- Polymers, microorganisms, and some types of natural gas are also generally exempt. However, a specific polymer, microorganism, or type of natural gas may lose its exemption if it is involved in certain TSCA actions, like an enforceable consent agreement.
Key TSCA Regulations and Import Certification Requirements
It is important to ensure that the company or individual fulfills all applicable TSCA regulations and other relevant statutes, such as the Clean Air Act and the Resource Conservation and Recovery Act, before importing TSCA-covered chemical substances, mixtures, or articles into the United States. Failure to meet TSCA guidelines can result in detained shipments, denied entry, and significant civil or criminal penalties.
Section 5:
Premanufacture Notification Rules: These Ensure that the EPA reviews new chemicals or significant new uses of chemicals before manufacture or import.
Significant New Use Rules (SNURs): Requires notification to the EPA before chemicals are used in ways that might create new exposures or risks.
Orders under Sections 5(e) and 5(f): It Includes restrictions or prohibitions on manufacturing, processing, or distribution of chemicals based on EPA’s risk evaluations.
Section 6: Rules and Orders
This section deals with limits or bans on chemicals that may harm health or the environment like polychlorinated biphenyls (PCBs) and asbestos. In addition, the importation of asbestos-containing products, such as flooring felt, commercial paper, corrugated paper, rollaboard, and specialty paper is also banned under TSCA.
Section 7: Judicial Actions: Addresses legal actions taken to address imminent hazards posed by certain chemicals.
Section 13: Import Certification Process: TSCA Section 13 requires importers to certify that their chemicals comply with TSCA regulations. Before entering the U.S., Importers must declare whether the chemical complies (“positive certification”) or is not subject to TSCA (“negative certification”).
TSCA Section 13 Import Certification Checklist
Importers must determine if their shipment requires TSCA certification by following these steps:
- Is the material an article, tobacco, or a tobacco product?
- Yes → No TSCA certification needed.
- No → Proceed to Step 2.
- Is the material a pesticide, nuclear material, firearm, ammunition, food, drug, cosmetic, or medical device?
- Yes → A negative certification is required unless clearly labeled under another regulation.
- No → Proceed to Step 3.
- Does the shipment contain chemicals regulated under TSCA Sections 5, 6, or 7?
- Yes → Proceed to Step 4.
- No → A positive certification can be made.
- Has the importer complied with TSCA Sections 5, 6, and 7?
- Yes → A positive certification can be made.
- No → The shipment cannot be imported until compliance is met.
Positive Certification Statement
A positive certification confirms that all chemical substances in the shipment comply with applicable TSCA regulations. The statement reads –
“I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order thereunder.”
Negative Certification Statement
The following is a negative certification statement.
“I certify that all chemicals in this shipment are not subject to TSCA.”
A negative certification is required for the chemicals:
- Pesticides, Fungicide & Rodenticide
- Food, food additives, drugs, cosmetics & device
- Nuclear Material, Tobacco and Tobacco Products
- Firearms and ammunition components
While positive TSCA certification is required for compliance with Sections 5, 6, and 7, importers must also be aware of additional sections of the Toxic Substances Control Act (TSCA) that may apply to their activities. It includes –
Section 4: Testing of Chemical Substances and Mixtures
EPA Authority: Under Section 4, the EPA can require manufacturers (including importers) and processors to conduct testing on the health and environmental effects of chemical substances and mixtures.
Importer Responsibility: Importers must follow Section 4 test rules unless they are exempt. Exemptions are found in regulations like 40 CFR Section 790.42 or specific test rules in Parts 766 or 799.
Continuing Obligation: You must follow the test rules for five years after you submit the test data. If it takes longer to develop the test data, you must follow the rules for that time instead.
Section 8: Reporting and Retention of Information
Section 8 requires importers to maintain records and report specific information to the EPA. Key rules include:
- Inventory Update Rule: Requires reporting of chemical substances manufactured or imported in significant quantities.
- Preliminary Assessment Information Reporting Rule: Requires reporting of preliminary data for certain chemicals.
- Chemical-Specific Recordkeeping and Reporting Rules: Mandates recordkeeping for specific chemicals.
- Allegations of Significant Adverse Reactions: Requires recordkeeping and reporting of adverse reactions to chemicals.
- Unpublished Health and Safety Data Reporting: Requires submission of unpublished health and safety studies.
- Substantial Risk Information Reporting (Section 8e): Requires reporting of information indicating substantial risks to health or the environment.
Section 12b: Export Notification Rule Applicability
Importers who also export chemicals may be subject to Section 12(b) requirements. This applies to chemicals:
- Subject to Section 5(b) data requirements
- Covered by orders or rules under Sections 5 or 6
- Involved in actions under Sections 5 or 7
TSCA Regulations & R&D Exemptions For Researchers
This exemption aims to allow research activities to be carried out while continuing the prohibition of commercial use of newly synthesized chemical molecules or hazardous chemicals.
If any researchers want to import or use new chemical molecules under the provisions of the Research and Development Exemption, then they must satisfy the requirements of the exemption as follows: –
- There should be no commercial sale or distribution of the material.
- The chemical substance must be purchased or synthesized in small quantities.
- The chemical substance must be used only by, or under the direct supervision of, a technically qualified individual.
- Knowledge of laboratory safety protocols, including storage & labeling of chemicals is necessary.
TSCA Challenges
The Toxic Substances Control Act (TSCA) was reformed after 40 years, but it still has major flaws:
- Slow Chemical Regulation – TSCA still follows a two-step process: risk assessment first, then risk management. This delays the regulation of harmful chemicals instead of preventing risks early.
- Lack of Focus on Safer Alternatives – The new TSCA does not prioritize safer substitutes early in the process, making chemical bans harder to implement.
- High Burden of Proof for Risk – Only risks supported by strong and unquestionable scientific evidence are likely to be considered, making it harder for the EPA to act on uncertain risks.
- Economic Considerations Over Health – The removal of cost and non-risk factors from risk assessment shifts economic concerns to risk management, making regulation less protective of public health.
- Industry Influence on Chemical Testing – TSCA now allows the industry to prioritize chemicals for risk evaluations, which could divert EPA’s attention from more harmful substances.
- Federal Preemption of State Regulations – The new TSCA limits the power of states to enforce stronger chemical regulations, except in certain cases like California law, reducing overall public health protection.
TSCA Compliance Roadmap: From Uncertainty to Full Approval
FAQs
Q. What if organizations fail to comply with TSCA?
Companies doing business in the U.S. must follow TSCA rules to make sure their chemical products meet legal requirements and avoid fines. Anyone who “knowingly or willfully” breaks any TSCA rules could face criminal penalties from the EPA. The EPA can fine up to $50,000 per day if the violation continues and/or send violators to prison for up to one year, or both.
Q. Who is subject to TSCA requirements?
Anyone who manufactures, imports, processes, or distributes chemicals within the United States must comply with TSCA regulations.
Q. How do I fill out a TSCA form?
To fill out a TSCA form, information about the chemical substances imported or manufactured is needed. It includes forms like the Pre-Manufacture Notice (PMN) and the Chemical Data Reporting (CDR) form.
Q. What are “articles” under TSCA?
Under the Toxic Substances Control Act (TSCA), “articles” are products that contain chemical substances or mixtures.
Q. How do I know if a chemical is subject to TSCA?
To know which chemical is subject to the Toxic Substances Control Act (TSCA), you need to check if it is listed on the EPA’s TSCA Chemical Substance Inventory.
Q. What is an impurity in TSCA?
A chemical substance that is unintentionally present with another chemical substance or occurs as a byproduct during the manufacturing process is referred to as an impurity.
Q. Who is an importer under TSCA?
A person or entity who brings a chemical substance (or mixture containing such substances) into the United States from a foreign country.
Q. How many chemicals are Banned in the US?
The EPA has banned nine chemicals under TSCA, including ethylene glycol, monochloroacetic acid, NDGA, and oil of calamus. Other chemicals of concern are asbestos, formaldehyde, lead, mercury, PFAS, PCBs, phthalates, BPA, and parabens.
Q. Is TSCA title vi compliant for formaldehyde?
TSCA title vi-compliant products are intended to be safe because they meet strict formaldehyde emission standards. It reduces formaldehyde emissions and the adverse health effects associated with them.
Disclaimer:
The information provided on this blog is for general informational purposes only and is based on publicly available sources, including regulatory guidelines and research publications. We do not provide legal, regulatory, or compliance advice regarding TSCA or any related regulations. Additionally, our content does not substitute for professional consultation with regulatory experts or legal professionals. Readers should conduct their due diligence and consult the appropriate authorities before making any compliance decisions.
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