• TSCA requires anyone who plans to manufacture (including import) a new chemical substance for a non-exempt commercial purpose to provide EPA with notice 90 days before initiating the activity.

Section 5 of the Toxic Substances Control Act (TSCA) gives the Environmental Protection Agency (EPA) the authority to require anyone who plans to manufacture (including import) a new chemical substance for a non-exempt commercial purpose to provide EPA with a premanufacture notice (PMN) or an exemption application at least 90 days before initiating the activity.

It should be noted that EPA considers certain genetically engineered microorganisms to be chemical substances for purposes of the notification requirements found in TSCA section 5. However, the 90-day notice for microorganisms is a Microbial Commercial Activity Notice (MCAN).

To determine if a substance is a “new” chemical, consult EPA’s TSCA Chemical Substance Inventory — commonly referred to as the Inventory, which lists “existing” substances. Any chemical that is not on the Inventory is considered a “new chemical substance.” Prior to manufacture (including import) of a new chemical for general commercial use, a notice must be filed with EPA under section 5 of TSCA.