The Toxic Substances Control Act (TSCA) is a United States law, passed by the United States Congress in 1976 and administered by the United States Environmental Protection Agency, that regulates the introduction of new or already existing chemicals.
Its three main objectives are to:
- assess and regulate new commercial chemicals before their entrance into the market,
- regulate chemicals (which were already existing in 1976) that posed an "unreasonable risk to health or to the environment", and
- regulate these chemicals' distribution and use.
On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Chemical Safety Act) was signed into law. The Lautenberg Chemical Safety Act amends the Toxic Substances Control Act (TSCA).
Toxic Substances Control Act (TSCA) requires EPA to compile, keep current and publish a list of each chemical substance that is manufactured or processed, including imports, in the United States for uses under TSCA. Also called the "TSCA Inventory" or simply "the Inventory.” It currently lists more than 86,000 chemicals.
If a chemical is on the Inventory, the substance is considered an "existing" chemical substance in U.S. commerce. Existing substances shall be followed with the Chemical Data Reporting (CDR) rule. The information is collected every four years from manufacturers (including importers) of certain chemicals in commerce generally when production volumes for the chemical are 25,000 lbs or greater for a specific reporting year. Collecting the information every four years assures that EPA and (for non-confidential data) the public have access to up-to-date information on chemicals.
The CDR rule is required by section 8(a) of TSCA and was formerly known as the Inventory Update Rule (IUR).
Any chemical not on the Inventory and its confidential portion is considered a “new chemical substance,” and manufacturers or importers must submit pre-manufacture notification (PMN) applications at least 90 days before they begin to manufacture or import a new chemical substance for a commercial purpose.
Once the EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture (including import), or process the chemical substance for that use.
The notification required by significant new use rules (SNURs), known as a SNUN, obligates the EPA to:
- assess risks that may be associated with the significant new use, including risks to potentially exposed or susceptible subpopulations identified as relevant by EPA under the conditions of use;
- make a determination under the statute; and,
- if necessary, regulate the proposed activity before it occurs.
In cases where the EPA determines that a new chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation under the conditions of use, EPA will notify the submitter of its decision under TSCA section then the companies could proceed with importation or manufacturing activities; if the agency finds an "unreasonable risk to human health or the environment," it may regulate the substance in a variety of ways, from limiting uses or production volume to outright banning them.
- TSCA inventory checking;
- pre-manufacture notification (PMN);
- PMN Exemption Notice;
- significant new use notice (SNUN); and
- Positive/Negative certificate.