This article is limited to defining the mandatory testing and TSCA (Toxic Substances Control Act) certification/labelling requirements in the US.

Terms & Definitions

A. TSCA stands for the Toxic Substances Control Act of 1976, which is a federal law in the United States that regulates the manufacture, distribution, import, and processing of chemicals.

B. Chemical inventory list is a record of all the chemicals present in a workplace or facility. It is a key component of a workplace‘s chemical management programme and helps to ensure that chemicals are properly identified, stored, handled, and disposed of.

Certification Requirement

The TSCA requires that certain chemical substances be reported to the Environmental Protection Agency (EPA) before they are manufactured, imported, or processed.

This certification is required for any chemical substance that is being imported into the United States. The certification must be provided by the manufacturer or importer of the chemical substance, and it must state that the substance complies with all applicable TSCA regulations.

To obtain TSCA certification, the manufacturer or importer must submit a TSCA Chemical Substance Inventory Form to the EPA, which identifies the chemical substance and provides information on its intended use.

The EPA will review the information and issue a TSCA certification if the substance is deemed to be in compliance with the TSCA regulations.

TSCA certification is important because it helps to ensure that chemical substances are safe for human health and the environment. By requiring certification, the TSCA helps to prevent the manufacture and importation of chemical substances that could pose a risk to public health or the environment.

The validity of a TSCA certification is typically one year, and it must be updated annually. However, if there are changes in the information provided in the original certification, such as changes in the identity of the importer or manufacturer, changes in the chemical substance or changes in the use of the chemical substance, a new certification must be submitted to the EPA.

It is important for companies to ensure that their TSCA certifications are accurate and up to date to avoid potential penalties or enforcement actions by the EPA.

Importance of TSCA for Textile products

The requirement for TSCA certification for textile products depends on the specific circumstances of the product and its intended use. In general, textile products are not considered to be chemical substances themselves, and therefore are not subject to TSCA certification. However, textile products may contain chemicals or substances that are subject to TSCA regulations, such as dyes or finishes.

If a textile product contains a chemical substance that is subject to TSCA regulations, then the manufacturer or importer of that chemical substance would need to obtain TSCA certification. For example, if a textile product contains a dye that is imported from overseas, then the importer of the dye would need to obtain TSCA certification for that substance before it can be legally imported into the United States.

It is also worth noting that textile products may be subject to other regulations related to their safety and composition, such as the Consumer Product Safety Improvement Act (CPSIA) and the Federal Trade Commission’s Textile Fiber Products Identification Act (TFPIA). These regulations may require testing and certification to ensure that textile products meet certain safety and labelling requirements.

Testing Requirement as per TSCA Act

The specific testing requirements depend on the nature of the chemical substance and its intended use. These are determined on a case-by-case basis.

The EPA may require a variety of testing, such as acute toxicity testing, chronic toxicity testing, reproductive and developmental toxicity testing, and environmental fate and effects testing. The testing may be required for the chemical substance itself, as well as any by-products or impurities that may be present.

The testing must be conducted by an accredited laboratory and must follow the EPA’s guidelines for test protocols, data collection, and reporting. The data obtained from the testing is used by the EPA to determine whether the chemical substance poses a risk to human health or the environment, and to establish any necessary regulations or restrictions on its manufacture, import, or use.

It is the responsibility of the manufacturer or importer of a chemical substance to ensure that it complies with the TSCA testing requirements before it is manufactured or imported. Failure to comply with the TSCA regulations can result in significant penalties and legal consequences.

When it comes to testing parameters for TSCA, the EPA generally requires companies to provide information about the physical and chemical properties of a substance, as well as its potential environmental and health effects. Some specific testing parameters that the EPA may require include:

I. Physical and chemical properties: Companies may be required to provide information about the substance’s melting and boiling points, solubility, vapour pressure, and other physical and chemical characteristics.

II. Toxicity and exposure: Companies may be required to conduct toxicity tests to determine the potential health effects of the substance, such as its ability to cause cancer or reproductive harm. They may also be required to provide information about how the substance is used and how it might be released into the environment, as well as estimates of exposure levels for workers and the general public.

III. Environmental fate and effects: Companies may be required to conduct tests to determine how the substance interacts with the environment, such as its potential to persist in the environment, bioaccumulate in organisms, or harm aquatic or terrestrial organisms.

IV. Endocrine disruption: If the substance is suspected of causing endocrine disruption (i.e., interfering with the hormonal systems of humans or animals), companies may be required to conduct tests to assess this potential effect.

The specific testing parameters that the EPA requires will depend on the characteristics of the substance being evaluated and the potential risks it may pose. Companies should consult with the EPA and follow its guidance when conducting tests and submitting information under TSCA.

TSCA Labelling Requirement

The TSCA regulations also require that certain chemical substances be properly labelled to ensure their safe use and handling. The specific labelling requirements depend on the nature of the chemical substance and its intended use. These are also determined on a case-by-case basis.

In general, chemical substances that are subject to TSCA regulations must be labelled with the following information:

The identity of the chemical substance: The name of the chemical substance as listed on the TSCA Chemical Substance Inventory.

Hazard warning: A description of the hazards associated with the chemical substance, including any acute or chronic health effects, and any environmental hazards. The hazard warning must be consistent with the EPA’s Hazard Communication Standard.

Precautionary measures: Information on the proper handling and use of the chemical substance, including any necessary personal protective equipment (PPE) and first-aid measures.

Documentation needed for Manufacturer for TSCA Certification

To obtain TSCA certification, the manufacturer must submit a Pre-Manufacture Notice (PMN) to the EPA at least 90 days prior to the manufacturing or importation of a new chemical substance. The PMN must include the following information:

• Chemical identity: The name of the chemical substance, its Chemical Abstracts Service (CAS) number, and its molecular formula.

• Manufacturing and processing information: The intended production volume of the substance, the manufacturing or importation site, and the manufacturing process.

• Potential exposure and risk information: The intended uses of the substance, including any proposed uses that may result in significant exposure to humans or the environment, and the results of any toxicity testing.

• Environmental release and waste management information: Information on the environmental fate of the substance, including any potential releases to the environment and plans for managing any waste associated with the substance.

The PMN is the primary document required for TSCA certification. However, the manufacturer may also need to submit other notifications, such as a Significant New Use Notice (SNUN), if they plan to use the substance in a new way that was not included in the original PMN. Additionally, manufacturers may be required to submit reports to the EPA on an ongoing basis to provide updates on the manufacture, processing, and use of the substance.