This guide briefly explains how manufacturers and importers can find out if a substance is on the Toxic Substances Control Act (TSCA) Inventory. The public TSCA Inventory only shows the non-confidential chemical identities, not the chemical identities claimed as confidential. The trouble is a facility must determine if a chemical is on the Inventory before it can begin to manufacture (or import) a new chemical substance — a substance not on the Inventory. How can a manufacturer (or importer) find that out if a portion of the TSCA Inventory is hidden from public view?

Bona fide notice

EPA explains that someone with a valid commercial need to verify if a substance is on the Inventory can submit a Bona Fide Intent to Manufacture or Import Notice (“bona fide notice”) to obtain a written determination from EPA. This notice is submitted to EPA via the Central Data Exchange (CDX), EPA’s electronic reporting site at https://cdx.epa.gov/.

Prior to submission to EPA via CDX, such bona fide intents to manufacture (including import) must be generated and completed using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to access the e-PMN software.

Each chemical reported in Bona Fide submission must contain the information specified at 40 CFR 720.25, this includes specific chemical identification data like the following:

• Chemical Abstracts Index name (proper CA Index names can be obtained from the Chemical Abstracts Service’s Inventory Expert Service);
• Information about the manufacture or importation of the substance;
• Letter of support if some information (e.g. specific chemical identity) has been withheld from the submitter by the supplier;
• Certification of intent to manufacture or import the substance for a commercial purpose; and
• All of the other information required in support of a bona fide notice.

EPA will consider the information submitted in a bona fide notice. If the agency believes that the submitter has demonstrated a genuine intent to manufacture or import, EPA will search the full TSCA Inventory master file and provide a written determination to the submitter on the TSCA Inventory status for the chemical substance.

Letter of support

EPA must be notified of any confidential chemical identity information (e.g., a reactant only known by a trade name is used in the manufacture of a chemical substance that is the subject of a bona fide notice).

Information that has been withheld from the submitter by a third party should be submitted directly to EPA by that third party (e.g., usually a domestic or foreign supplier or manufacturer). In its letter of support, the third party must provide chemical identity information for the confidential substance as specified in the amended regulation at 40 CFR 720.45(a).

If confidential substances are involved and require a third party letter of support, a bona fide notice submitter must keep in mind that all supporting material must be received by EPA for a bona fide notice to be considered complete. A submitter should also have an agreement with its supplier to ensure being informed of any changes in composition that can change the chemical identity of the confidential substance.

Manufacturers and importers whose reportable substances are manufactured with branded materials that have confidential components should take steps to be informed in a timely manner if the branded materials change in composition. EPA does not use brand names in listing substances on the TSCA Inventory, in part because branded materials formulations can change and in part because the TSCA Inventory identifies and lists specific chemical substances and not formulations.