• “Existing” chemicals are chemicals that were already in commerce when TSCA was enacted in 1976 or chemicals that have undergone PMN review and are listed on the TSCA Inventory.

Under Toxic Substances Control Act (TSCA) section 5, chemical manufacturers (or importers) must submit a notice to the Environmental Protection Agency (EPA) at least 90 days prior to the initial commercial manufacture (or import) of a new chemical substance, unless the chemical substance meets certain criteria for an exemption from notification. This notification is known as a premanufacture notice (PMN). According to EPA, the agency has received more than 40,000 PMNs since the enactment of TSCA in 1976.

Introduction

Mandated by section 5 of TSCA, EPA’s New Chemicals program helps manage the potential risk to human health and the environment from chemicals new to the marketplace. The program functions as a “gatekeeper” that can identify conditions, up to and including a ban on production, to be placed on the use of a new chemical before it is entered into commerce.

For purposes of regulation under TSCA, if a chemical is on the TSCA Inventory, the substance is considered an “existing” chemical substance in U.S. commerce. “Existing” chemicals are chemicals that were already in commerce when TSCA was enacted in 1976 or chemicals that have undergone PMN review and are listed on the TSCA Inventory.

Who must submit a PMN?

Section 5 of TSCA requires anyone who plans to manufacture (including import) a new chemical substance for a non-exempt commercial purpose to provide EPA with notice before initiating the activity. This notice is known as a PMN. Refer to the chart below that details steps for determining whether a submission is required on a chemical substance.