The Toxic Substances Control Act (TSCA) regulates both chemicals and substances in articles. In this guide, we explain what Toxic Substances Control Act (TSCA) means in practice for importers and manufacturers, in terms of scope, certification, labeling, and lab testing requirements.
What is the Toxic Substances Control Act?
The Toxic Substances Control Act (TSCA) is an act that was passed in 1976 to regulate the production, import, use, and disposal of certain chemicals in the United States. The TSCA authorizes the Environmental Protection Agency (EPA) with the authority to issue substance restrictions, administer reporting, record-keeping, and testing, regarding chemical substances.
The TSCA’s requirements for importers or manufacturers of covered products include:
- Reporting the products to the EPA
- Keeping records (e.g. records related to purchasing, or sales)
- Testing products according to required standards or test methods
- Obtaining certain certifications for the products
- Correctly label the products and their packaging
The TSCA also requires similar procedures for chemicals. Additionally, importers and manufacturers of new chemical substances must submit a new chemicals notice to the EPA.
Which Substances are Regulated by the TSCA?
The TSCA lists 86,607 chemicals under the “TSCA Inventory”. The public can get access to the non-confidential part of the TSCA Inventory on the EPA’s official website.
The TSCA regulates several substances that are deemed toxic and might be found in articles. Here are some examples:
- Persistent, Bioaccumulative, and Toxic (PBT)
- Polychlorinated biphenyls (PCB)
Due to the large number of chemicals recorded in the Inventory, the TSCA uses special flags to identify and group the chemicals for easier management. For flagged chemicals, different requirements might apply according to the flag, including testing, reporting, labeling, or certification. Examples of flagged chemicals include:
- Polychlorinated biphenyls (PCBs)
If a chemical is listed in the inventory but is not flagged, importers or manufacturers must issue a negative certification statement and submit it to the United States Customs and Border Protection, declaring that the chemicals in the shipment are not subject to the TSCA.
Chemicals that are not listed in the inventory are deemed as “new”. Importers or manufacturers of chemicals that are not in the TSCA Inventory must submit a pre-manufacture notice (“PMN”) to EPA at least 90-days before manufacturing or importing new chemical substances in the United States.
The TSCA mandates the EPA to compile a list of chemical substances that are manufactured, imported, or processed in the United States. As already mentioned, this list is called the “TSCA Inventory”.
The inventory is updated every six months and it plays an important role in the regulation of chemicals in the United States. Currently, it contains 86,607 chemicals.
Among the 86,607 chemicals in the TSCA Inventory List, some receive special attention, in the sense that is also restricted in several classes of articles. This includes:
a. Formaldehyde, which might be found in composite wood products
b. PBT, which might be found in plastic products and components, textiles, or rubber products
b. PCB, which could be used in voltage regulators, switches, reclosers, and other electrical products
c. Mercury, which could be used in batteries, thermometers, or lighting products, among others.
The chemicals listed in the TSCA Inventory are categorized and flagged by the EPA according to the requirements that apply to a specific chemical. Different flags trigger different requirements, such as testing, reporting, export prohibition, or others.
Here we list two examples:
a. Chemicals with the 5E flag are subjected to the TSCA section 5(e) order, which includes restrictions on releases to water, air, and land, recordkeeping, and use of personal protective equipment for employees that work in proximity of the substances
b. Chemicals with the 5F flag are subjected to the TSCA section 5(f) rule, which limits the amount of the substance that can be manufactured, processed, or distributed in commerce
Substances Restrictions in Articles (Products)
Some TSCA’s substance restrictions apply to articles in general, such as the restrictions of PBT. Some restrictions only apply to certain categories of products, such as the restriction of formaldehyde level in composite wood products.
Persistent, Bioaccumulative, and Toxic (PBT)
The TSCA prohibits the use of five persistent, bioaccumulative, and toxic chemicals under Part 751 of the Code of Federal Regulation. These prohibited PBTs might be used in various consumer and industrial products as plasticizers, flame retardants, anti-wear additives, or an anti-compressibility additive.
These five restricted PBT and their maximum allowable limit on articles are:
- 2,4,6-TTBP ≤ 0.3% by weight
- DecaBDE: Prohibited
- PIP 3:1: Prohibited)
- PCT ≤ 1% by weight
- HCBD: Prohibited
Below we list articles that might contain PBT. Some of these examples are taken from the PBT guidance on EPA’s website (although they are not listed in the regulation itself):
- Power sockets
- Plastic electronic components
- Plastic enclosures for electronic equipment
- Wire and cables
- Textiles and apparels
- Upholstered furniture
TSCA’s Title VI Section 770 establishes rules for the formaldehyde emission of composite wood products manufactured, imported, and distributed in the United States.
The emission limits are tested using the following ASTM standards, which have been incorporated by the TSCA:
a. ASTM E1333-14 Standard Test Method for Determining Formaldehyde Concentrations in Air and Emission Rates from Wood Products Using a Large Chamber
b. ASTM D6007-14 Standard Test Method For Determining Formaldehyde Concentrations In Air From Wood Products Using A Small-Scale Chamber
Below are examples of composite wood products that are specifically mentioned in the act, and their respective formaldehyde emission limits:
a. Hardwood plywood < 0.05 parts per million (ppm) of formaldehyde
b. Particleboard < 0.09 ppm of formaldehyde
c. Medium-density fiberboard < 0.11 ppm of formaldehyde
d. Thin medium-density fiberboard < 0.13 ppm of formaldehyde
The TSCA requires that importers or manufacturers of mercury or mercury-added products must report to the EPA the following information before selling their products:
- Products’ country of origin
- Products’ countries of destination
- NAICS code
Below are products that are specifically mentioned under the TSCA:
- Silver button cell batteries
- Zinc-air button cell batteries
- Linear fluorescent lighting
- Neon lighting
- Measuring instruments
- Skin-lightening creams
Polychlorinated Biphenyls (PCB)
The TSCA prohibits the import, manufacture, and distribution of Polychlorinated Biphenyls (PCBs) and PCB items. These requirements are incorporated in Part 761 of the Code of Federal Regulation.
The prohibition has been enforced in the United States since 1979. Nowadays, most other countries prohibit the manufacturer and use of PCBs. Therefore, it is unlikely that products produced recently contain PCB.
PCB were commonly used in electrical equipment before being subject to prohibition. Below are examples of products that might contain PCB, which are specifically mentioned under the TSCA:
- Fluorescent light ballast
- Voltage regulators
Importers and manufacturers must issue a certification for imported and manufactured chemicals, and for some classes of articles.
Composite Wood Product Certification
The TSCA requires that composite wood product importers and manufacturers must apply for certification with the EPA, by providing information such as:
a. Contact information of the panel producer and quality control manager
b. Copy of the panel producer’s quality control manual as required by section 770.21(a)
c. Product information and the resin system used in panel production
d. Valid test report in accordance with the ASTM E1333-14 or ASTM D6007-14
Positive Certification Statement for Chemicals
Importers and manufacturers need to issue either a positive certification or negative certification when importing chemical substances or articles to the United States. A positive certification is needed for substances that are flagged in the TSCA Inventory or substances that aren’t listed in the inventory and thus are deemed as “new substances”.
The TSCA positive certification statement is meant to declare that the chemical complies with all applicable TSCA requirements, and should include the following wording:
“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 for Chemicals
On the other hand, if the chemicals are not flagged in the TSCA inventory, importers and manufacturers need to issue a negative certification, which should include the following wording:
“I certify that all chemicals in this shipment are not subject to TSCA.”
The TSCA specifies labeling requirements for certain chemicals and products. Below are examples of the labeling requirements.
The TSCA sets labeling requirements for some products, such as composite wood products. For this type of product, the label should contain the following information:
- Panel producer’s name
- Lot number
- Third-party certification number accredited by the EPA
- A statement to clarify that the products are TSCA Title VI compliant
Under the TSCA, labeling might be necessary for some chemicals as well. For example, the TSCA requires that whoever distributes metalworking fluid containing mixed mono and diamides of organic acid must affix a label to each container containing the fluid. The label should contain carcinogenic warnings and icons.
Importers and manufacturers of chemicals must keep records and report on the identity, use, volume, byproducts, and other data to the EPA as required by the TSCA.
Articles containing some regulated chemicals (e.g. mercury) might also be subject to the reporting requirements.
The TSCA requires importers and manufacturers of the following products to report to the EPA:
- Mercury-added products
- Composite wood products
- Products containing PCB
Examples of chemicals that are required to report to the EPA include:
- Some classes of phthalates (for example BBP, DBP, Dicyclohexyl phthalate, DEHP, DIBP)
- Some classes of flame retardants (for example TBBPA, TPP, TCEP)
Lab Testing Requirements
Under the TSCA, lab testing might be explicitly required for some products (e.g. composite wood products). Even if testing is not explicitly required, you might still need to test your product to make sure it doesn’t contain restricted substances above the limits.
These are companies that offer TSCA-related lab testing services:
- Berkeley Analytical Associates
- UL Environment
Products that are not regulated by the TSCA include:
- Tobacco products
These products are subject to the respective federal or state regulations such as the Food, Drug, and Cosmetic Act (FDCA).