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What is the TSCA Chemical Substance Inventory?

EPA classifies chemical substances as either "existing" chemicals or "new" chemicals. The only way to determine if the substance you are working with is a new chemical is by consulting EPA's Toxic Substances Control Act Chemical Substance Inventory (commonly referred to as the TSCA Inventory or just the Inventory). Any substance that is not on the Inventory is classified as a new chemical. If a substance is "new", it can be manufactured for a commercial purpose only if it is subject to an exemption from PMN reporting or a TSCA reporting exclusion (for example, a Low Volume Exemption, or exclusion as a naturally-occurring material). For substances which are "existing", the Inventory can be used to determine if there are restrictions on manufacture or use under the Toxic Substances Control Act (TSCA)Exit Disclaimer.There are approximately 75,000 chemical substances, as defined in Section 3 of the TSCA, on the Inventory at this time.

TSCA Section 8 Exit Disclaimer required EPA to issue regulations for an inventory of chemical substances manufactured for commercial purposes ("manufactured" includes "imported" for purposes of this requirement). Manufacturers and importers of chemical substances were required to submit information about chemical substances already in commerce during an initial reporting period for the Initial Inventory. Since the Initial Inventory was published, intending non-exempt commercial manufacturers or importers of substances not on the Inventory have been required to submit notices to the Agency under Section 5 of the TSCA most are PMNs. PMNs not disapproved by the Agency, and for which the submitters file Notices of Commencement of Manufacture/Import (NOCs), become new listings on the Inventory. Non-PMN submissions (LVEs, LoREXs, TMEA) and exempt uses not subject to submission (R&D) are not followed by inventory listing. The Agency has developed policy about how to identify chemical substances for the purpose of assigning a unique and unambiguous description of each substance for the Inventory. Several papers giving Inventory nomenclature guidance are available, covering TSCA Inventory representation for:

Instructions for developing generic names for use in PMN submissions are contained in the TSCA Inventory, 1985 Edition, Appendix B: "Generic Names for Confidential Chemical Substance Identities(477 Kb PDF).

The public Inventory of substances whose chemical identities are not claimed confidential is published from time to time by the Agency. An extract of the public Inventory Exit Disclaimerhas been posted by Cornell University. Although the paper version of the nonconfidential Inventory is not published frequently, electronic media versions (diskettes, computer tapes, CD-ROM) are updated and published twice a year. A substance whose identity is confidential will be searched in the Confidential Inventory by the Agency upon receipt of a Notice of Bona Fide Intent to Manufacture.

A substance which was placed on the Inventory due to submission of an Initial Inventory report or which, as a result of submission of an NOC after PMN since that time, has been added to the Inventory, is considered an "existing" chemical. Substances not on the Inventory are "new" chemicals. The only way to determine if a given substance is "new" is to consult the Inventory. Most Inventory substances are in the non-Confidential version of the Inventory. A majority of the substance, now being added through commenced PMNs, however, are confidential.

How can the TSCA (Toxic Substances Control Act) Inventory be consulted?

The TSCA Inventory is available in paper form as well as on computer tape, diskettes, or CD-ROM. The TSCA Inventory in paper form was updated in 1990 and does not reflect additions to the Inventory since then. The electronic-medium Inventories are updated every six months. EPA does not provide searches of the non-confidential TSCA Inventory, but there are a number of ways you can research whether a chemical is listed on the non-confidential portion of the TSCA Inventory:

When is a new chemical substance added to the TSCA Inventory?

A new chemical is eligible for addition to the TSCA Inventory after the PMN review has been completed. The company that submitted the PMN must provide a Notice of Commencement of Manufacture or Import (NOC) (EPA Form 7710-56) to EPA within 30 days of the date the substance is first manufactured or imported for nonexempt commercial purposes. After a NOC is reviewed, the chemical will be listed. Once a substance is listed on the TSCA Inventory, it is considered an existing chemical.

In considering use of an existing chemical, a user will need to determine whether the substance is subject to other rules under the TSCA. For this, consult the Chemicals on Reporting Rules Database (CORR), available as an electronic database from the TSCA Hot Line. New rules which control use of a substance will be notified in the Federal Register.

How can it be determined whether a substance is a new chemical if its identity is a trade secret?

The identity of an existing chemical that has been claimed as confidential business information will not be listed on the public portion of the TSCA Inventory. In these cases, EPA will search the confidential portion of the TSCA Inventory for you if you demonstrate, in writing, a bona fide intent to manufacture or import the chemical substance.

For more information about submitting a Notice of Bona Fide Intent to Manufacture or Import (bona fide) inquiry, see 40 CFR Section 720.25 or contact the TSCA Assistance Information Service.

In some cases, a manufacturer will want to use reactants whose identities are held confidential by their suppliers from the manufacturer. In certain other cases, a potential importer wants to bring into the US a substance whose identity is known only to its foreign manufacturer. In these cases a letter of support from the domestic manufacturer or foreign reactant manufacturer sent directly to EPA, giving complete chemical identity, health and safety information, etc., can be used for Section 5 notification.

[PDF] PLEASE NOTE: Some of the documents mentioned in this Section are in Adobe's Portable Document Format (PDF). To view or print them you will need to have the Reader program installed on your computer. The Reader can be downloaded and used with no charge; check here for more information on the Reader.

 

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