Expert information on TSCA
The United States Toxic Substances Control Act (TSCA)
The United States Toxic Substances Control Act (TSCA) regulates most industrial chemicals manufactured or processed in the United States. It covers all substances that pose an “unreasonable risk to health or the environment” and applies to imports, too. The legislation was passed in 1976 alongside various other environmental regulations in the U.S. and was extensively reformed in 2016. The law regulates various chemicals and substances, including asbestos, lead in paint, nanomaterials, and polychlorinated biphenyls (PCBs). Whether the law can also be applied to control greenhouse gas emissions is a point of contention that is currently being decided in court.
The TSCA Inventory (or simply “the Inventory”) is a list of chemical substances covered by the TSCA. The U.S. Environmental Protection Agency (EPA) keeps it up to date and publishes changes every six months in a non-confidential section of the inventory. The list can be viewed using a search function free of charge on the EPA’s website.The most current version can also be downloaded directly from the EPA website. The first version of the inventory listed 62,000 chemical substances, but it now covers 86,000 chemical substances. The EPA receives about 400 new substance notifications each year, which means the TSCA Inventory changes on a daily basis. Twice a year, the EPA updates its publicly available information on the TSCA Inventory to include new and corrected versions of the chemical listings. Confidential chemical identities are not included in this. This means that the information available to the public is less complete and current than the information held in the EPA’s TSCA master inventory file, which can only be viewed by the EPA. This file also contains the chemical identities that are classified as confidential and is always kept up to date as new or corrected information is received. Consequently, authoritative and complete information is only available through the EPA’s official channel.
Searching the TSCA Inventory is not easy. A member of our team at imds professional would be happy to help with this task. Don’t hesitate to contact us to find out more. We can help you search the public part of the inventory and register substances in accordance with TSCA requirements.
“Chemical substances” in the TSCA Inventory include both organic and inorganic substances and polymers. It also includes chemical substances of unknown or variable composition, complex reaction products, and biological materials (known collectively as UVCBs). There are other chemical substances that are not listed in the TSCA Inventory but that are regulated by other U.S. laws, such as pesticides, food or food additives, cosmetics, drugs, tobacco and tobacco products, nuclear materials, and munitions. Chemicals not listed in the inventory are considered to be a “new chemical substance”. Substances with manufacturing or usage restrictions are identified with flags in the TSCA Inventory.
Before a chemical substance is manufactured or imported, it must be verified to ensure it is included in the inventory. Section 5 of the TSCA specifies that the EPA must receive a Premanufacture Notice (PMN) for all chemical substances that are not exempt for certain commercial uses at least 90 days prior to the start of manufacture or importation.
The EPA recommends that any organizations submitting a Premanufacture Notice (PMN) ensure the data is accurate and complete. It is therefore important to ensure that the relevant EPA regulations are carefully considered. The EPA has provided various guidance documents to help avoid incomplete PMNs on its website. There is also an Instruction Manual for Premanufacture Notification of New Chemical Substances available to download as a PDF. The information in the PMN notification form should be accurate and complete. If this is not the case, the EPA may request further information or revisions to the risk assessment, which can delay the process. The EPA may declare that the application is incomplete during the review period and suspend its review. Any organization that receives additional risk-related information or test data for a new chemical during this review period must submit it to the EPA within 10 days, but no later than five days before the end of the review period or notify their EPA contact by telephone after this period. This includes toxicological information but also other areas such as the release of chemicals into the environment, occupational safety, and details relating to manufacturing, use, and disposal.
Any organization looking for a particular substance in the TSCA Inventory for commercial reasons and that is intending to manufacture it, must submit what is known as a Bona Fide Intent Notice (also known as an Import Notice) to the EPA. This must detail various information about the substance. Among other things, the information must include the name specified in the Chemical Abstracts Index. The CA Index name can be provided by the Chemical Abstracts Service’s Inventory Expert Service, a division of the American Chemical Society. Additional information must be submitted to the EPA relating to confidential chemical identity, i.e., if a supplier has withheld certain information from the submitter. In this case, the submitter needs a letter of support from the supplier or manufacturer in question, who must provide information on the chemical identity of the confidential substance directly to the EPA. This documentation must be received by the EPA before a Bona Fide Intent Notice or the PMN is considered to be complete by the EPA. The EPA advises that arrangements are made to ensure suppliers are notified of any changes in the composition of the substances. This is because any changes could also alter the chemical identity of the confidential substance. This could be the case, for example, when manufacturers and importers use reportable substances with branded materials that contain confidential ingredients. The EPA does not use brand names in the TSCA Inventory because their formulations can change and because specific chemical substances are listed in the inventory, not formulations. Further information on the Bona Fide Intent Notice is also available directly on the EPA’s TSCA hotline.
The final step in the EPA review process is the Notice of Commencement of Manufacture or Import, known as NOC for short, which can also be submitted electronically. This step occurs after the EPA has reviewed the Premanufacture Notice. Anyone submitting a PMN must electronically submit the NOC form to the EPA within 30 calendar days after the date the substance is first manufactured or imported for non-exempt commercial purposes. If the NOC is complete, the EPA will list the substance on the TSCA Inventory. The relevant date is the date the EPA receives the completed NOC, even if the actual processing takes about four weeks. The substance is then considered to be an “existing chemical” from the date the completed NOC is received by the EPA.
Substances that fall under the Research and Development (R&D) Exemption, i.e., manufactured in small quantities and solely for research and development, do not require an NOC and may be used or sold after the PMN review period. However, they will not be included in the TSCA Inventory until an NOC is available. This in turn may not be submitted until commercial production begins and the substance is no longer in the research and development phase.
There are further exemptions for low volume exemptions (LVEs), low release/low exposure exemptions (LoREXs), test market exemptions (TMEs), and polymers that comply with the Polymer Exemption Rule Amendments of 1995. NOCs are not required for such substances and for uses that do not require notification. They are also not included in the TSCA inventory.
Many nanoscale materials also fall under the TSCA and are classified as “chemical substances.” Substances with dimensions at the nanoscale, i.e., approximately 1 to 100 nanometers (nm), are referred to as nanomaterials or nanoscale materials or substances. For comparison, a human hair is 80,000 to 100,000 nanometers. A nano-sized chemical substance can have different properties than the same chemical substance with larger structures. For example, the substance may become stronger or lighter and also have higher chemical reactivity. This is often useful for commercial applications, but for some substances, it also leads to a change in their impact on the environment or health. To avoid risks in this regard, the EPA has comprehensively regulated nanomaterials. It collects information on new and existing nanomaterials and ensures that pre-notifications are available for new nanomaterials. Companies must provide the EPA with information about specific chemical substances that are already on the market, manufactured, imported, or processed as nanoscale materials. This includes details on the specific chemical identity, production volume, manufacturing methods, health and safety data, and information on the processing, use, exposure, and release of the substances. The EPA has developed guidance on collecting information on nanoscale materials for manufacturers, importers, and processors. The EPA has compiled guidance to help organizations determine whether a nanoscale substance is a “new” chemical in the TSCA inventory.
To limit the risk from nanomaterials, the EPA has limited their use in some cases, as well as their release into the environment, or requires the use of personal protective equipment and specific technical control measures. It also requires testing on health and environmental data. The manufacture of new nanoscale chemical materials is permitted under the TSCA to a limited extent. “Consent orders” or “significant new use rules” (SNUR) are used for this purpose. The production of new chemical materials at the nanoscale can also be permitted under certain exemptions. However, strict rules apply to control exposure and avoid unacceptable risks such as their release into the environment.