- What Does It Mean for a Chemical To Be on the TSCA Inventory?
- How Are Chemicals Added to the TSCA Inventory
- How To Get a Determination If a Chemical Is on the Inventory -- Submit a Bona Fide Intent to Manufacture or Import Notice
Under TSCA, the term 'chemical substance' means any organic or inorganic substance of a particular molecular identity, including any combination of these substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any element or uncombined radical. Chemicals substances on the Inventory include: organics, inorganics, polymers, and UVCBs (chemical substances of unknown or variable composition, complex reaction products, and biological materials). The Inventory, nor TSCA, covers chemical substances subject to other U.S. statutes, such as foods and food additives, pesticides, drugs, cosmetics, tobacco, nuclear material, or munitions.
As new chemicals enter commerce, the number of chemicals on the Inventory changes. Today more than 84,000 chemical substances are on the Inventory. The initial reporting period was January to May of 1978, for chemical substances that had been in commerce since January of 1975. The initial TSCA Inventory, published in 1979, was followed by a second version in 1982, which included approximately 62,000 chemical substances.
As part of EPA’s commitment to strengthen chemical management and increase information on chemicals, for the first time, in 2010, EPA provided free Web access to the inventory and made it available on Data.gov, a government-wide Website developed to provide public access to important government federal information.
Substances on the TSCA Inventory are considered "existing" chemicals in U.S. commerce, and substances not on the TSCA Inventory are considered "new" chemicals. If a substance is determined to be a "new" chemical substance for TSCA purposes, it is subject to TSCA section 5 Premanufacture Notice (PMN) requirements, unless the substance meets a TSCA reporting exclusion (e.g., is a naturally-occurring material) or is exempt from PMN reporting (e.g., is an exempted polymer). (The TSCA Inventory must be consulted to determine if a specific substance is "new" or "existing.") For substances that are "existing" chemical substances in U.S. commerce, the TSCA Inventory can be used to determine if there are restrictions on manufacture or use.
After PMN review has been completed, the company that submitted the PMN must provide a Notice of Commencement of Manufacture or Import (NOC) (EPA Form 7710-56) to EPA within 30 calendar days of the date the substance is first manufactured or imported for nonexempt commercial purposes. A chemical substance is considered to be on the TSCA Inventory and becomes an existing chemical as soon as a complete NOC is received by EPA. The Agency receives between 500 and 1,000 NOCs each year, thus the TSCA Inventory changes daily.
Non-PMN submissions (Low Volume Exemptions - LVEs, Low Release/Low Exposure Exemptions - LoREXs, Test Market Exemptions - TMEs) and exempt uses not subject to submission (R&D) do not require an NOC and are not listed on the TSCA Inventory.
If an intended manufacturer or importer of a chemical substance is unsure of the TSCA Inventory status of the chemical (e.g., cannot find that substance on one of the public sources of non-confidential TSCA Inventory data), the company or representative can obtain a written determination from EPA if it can demonstrate a “genuine intent.” It can do this by submitting a Bona Fide Intent to Manufacture or Import Notice pursuant to the procedures at 40 CFR section 720.25.
Bona Fide Intent to Manufacture or Import Notice
In a bona fide notice, a submitter must:
- Provide specific chemical identification data including the Chemical Abstracts Index name as well as information about the substances' manufacture or importation. Proper CA Index names can be obtained from the Chemical Abstracts Service's Inventory Expert Service
- Possibly submit a letter of support (see below). This may can be necessary if some information is withheld from the submitter by, for example, a supplier
- Certify intent to manufacture or import the intended substance for a commercial purpose
- Provide all of the other information required in support of a bona fide notice.
In some cases, a potential manufacturer may be intending to use reactants whose specific chemical identities are held confidential by their suppliers. In certain other cases, a potential importer may be intending to bring into the United States a substance whose identity is known only to its foreign manufacturer. In these cases, a letter of support from the domestic or foreign manufacturer of the confidential substances can be provided directly to EPA and should include specific chemical identity information. When using a Branded Material of Confidential Composition users will need information from their suppliers to ensure that they are and remain in compliance.
Instructions on Notices of Bona Fide Intent to Manufacture are available from the TSCA Hot Line.
Specific chemical identity information is required for Bona Fide Intent to Manufacture or Import Notices, Premanufacture Notices, and other purposes under TSCA. EPA must be notified of any confidential chemical identity information (e.g., a reactant only known by a trade name is used in the manufacture of a chemical substance that is the subject of a bona fide notice or PMN). Information that has been withheld from the submitter by a third party should be submitted directly to EPA by that third party (e.g., usually a domestic or foreign supplier or manufacturer). In its letter of support, the third party must provide chemical identity information for the confidential substance as specified in the amended regulation at 40 CFR section 720.45(a).
If confidential substances are involved and require a third party letter of support, a bona fide notice or PMN submitter must keep in mind that all supporting material must be received by EPA for a bona fide notice or PMN to be considered complete. A submitter should also have an agreement with its supplier to ensure being informed of any changes in composition that can change the chemical identity of the confidential substance.
Manufacturers and importers whose reportable substances are manufactured with branded materials that have confidential components should take steps to be informed in a timely manner if the branded materials change in composition. EPA does not use brand names in listing substances on the TSCA Inventory, in part because branded materials formulations can change and in part because the TSCA Inventory identifies and lists specific chemical substances and not formulations.