TSCA
The Toxic Substances Control Act (TSCA) was enacted in 1976 to ensure that chemicals manufactured, imported, processed, or distributed in commerce, or used or disposed of in the United States do not pose any unreasonable risks to human health or the environment. Core regulatory provisions include TSCA section 4 (testing of chemical substances and mixtures), TSCA section 5 (manufacturing and processing notices), TSCA section 6 (regulation of hazardous chemical substances and mixtures), and TSCA section 8 (reporting and retention of information).
TSCA section 8(b) provides EPA authority to “compile, keep current, and publish a list of each chemical substance that is manufactured or processed in the United States.” TSCA section 3(2)(A) states that “the term ’chemical substance’ means any organic or inorganic substance of a particular molecular identity, including - (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and (ii) any element or uncombined radical.” TSCA does not include chemical substances subject to other US statutes such as foods and food additives, pesticides, drugs, cosmetics, tobacco, nuclear material, or munitions.
EPA published the final TSCA Inventory Reporting Rule on December 23, 1977. The initial reporting period was January to May of 1978, for chemical substances in commerce since January of 1975. The initial TSCA Chemical Substance Inventory was published in 1979; a second version was published in 1982 (?) and included approximately 62,000 chemical substances provided to EPA during the initial and follow-up reporting periods. Through the addition of new chemicals in commercial TSCA applications in the US, there are more than 83,000 chemical substances, as defined in TSCA section 3(2)(A) - among them as organics, inorganics, polymers, and UVCBs (chemical substances of Unknown, or Variable composition, Complex reaction products, and Biological materials) - on the Inventory at this time.
Substances on the TSCA Inventory are considered “existing” chemicals in U.S. commerce, and substances not on the TSCA Inventory are “new” chemicals. The TSCA Inventory must be consulted to determine if a specific substance is “new” or “existing.”
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). 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.
In some cases, a 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 U.S. 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.