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Anyone who intends to manufacture (including import) a “new chemical substance” for a non-exempt commercial purpose is required to submit a pre-manufacture notice (PMN) at least 90 days prior to the manufacture of the chemical. If a chemical is on the Toxic Substances Control Act (TSCA) Inventory, the substance is considered an “existing” chemical substance in U.S. commerce. Therefore, any chemical that is not on the Inventory is considered a new chemical substance.
After EPA risk assessors consider all of the submitted information during the EPA new chemicals review process, the agency makes a final determination whether to allow the chemical to enter into commerce and whether to set restrictions for entering into commerce. This process ensures that new chemicals that enter into commerce do not present an unreasonable risk to human health or the environment.
Note: This ezExpanation does not cover reporting requirements for microorganisms per 40 CFR 725.
Mandated by Section 5 of TSCA, the following persons must submit a premanufacture notification unless the substance is excluded under 720.30:
Notes: If it is unclear who must report, EPA should be contacted to determine who must submit the notice. When several persons are involved in an import transaction, the notice must be submitted by the principal importer, but if no one person fits the principal importer definition in a particular transaction, the importer should contact EPA to determine who must submit the notice for that transaction.
A summary of requirements includes the following:
In addition, it is a good idea to consider the following: