TSCA New Chemical Review and Premanufacture Notification

The starting point is the chemical substance, rather than a trade name or finished formulation. EPA distinguishes new substances from existing substances by the TSCA Chemical Substance Inventory. Review each constituent of a mixture and resolve confidential identities through the appropriate supplier and EPA procedures. A substance absent from the public list may appear on the confidential Inventory; a documented bona fide inquiry can resolve that question.

Part 720 specifies who must report and the information included in a premanufacture notice. Manufacturing includes importing for this purpose. A covered notice must precede commercial activity by the applicable review period, ordinarily at least 90 days. Research, polymer, low-volume and other exemptions have their own conditions; an exemption assessment should identify the exact provision and the activities it permits.

The notice addresses chemical identity, production or import volume, uses, manufacturing processes, exposure, releases and disposal. Available health and environmental test data and other reasonably ascertainable information are part of the submission framework. Supplier confidentiality should be managed through EPA's established procedures, rather than by omitting identity information. Completeness review and subsequent information requests can affect the planned introduction schedule.

EPA review can lead to a determination allowing activity or to restrictions, orders or prohibitions. Quality and production personnel need the operative outcome, including any limitations on use, worker protection, releases or distribution. The supply specification should identify restrictions that downstream processors must observe. A notice acknowledgment alone does not establish that the review is complete or that every intended use is permitted.

An Inventory entry establishes a regulatory status, not a finding that the chemical is safe for every application. Existing substances can remain subject to significant new use rules and other TSCA restrictions. Food, drug, cosmetic, pesticide and other excluded uses require a separate jurisdictional analysis. The same chemistry may therefore require different reviews according to the use for which it is manufactured or distributed.

Keep the identity determination, reporting or exemption rationale, submission record, EPA correspondence and operative restrictions with the controlled substance specification. Reassess the file when the composition, supplier, production volume, process, exposure scenario or intended use changes. Purchasing, regulatory affairs and production should work from the same approved identity and use description, especially when imported materials are supplied under confidential commercial names.