Introduction

This fact file provides an overview of the Toxic Substances Control Act (TSCA) Inventory.

Background

Section 8(b) of Toxic Substances Control Act requires the Environmental Protection Agency (EPA) to compile, keep current, and publish a list of each chemical substance that is manufactured or processed, including imports, in the U.S. for uses under TSCA. Also called the “TSCA Inventory” or simply “the Inventory,” it plays a central role in the regulation of most industrial chemicals in the U.S.

The initial reporting period by manufacturers, processors, and importers was January to May of 1978 for chemical substances that had been in commerce since January of 1975. The Inventory was initially published in 1979, and a second version, containing about 62,000 chemical substances, was published in 1982. The TSCA Inventory is updated every six months, if possible, and has continued to grow. It now lists more than 86,000 chemicals, of which about 42,200 are active.

Since compiling the initial TSCA Inventory, TSCA section 5 requires that any person who proposes to manufacture (which includes import) a “new chemical,” i.e., a chemical not listed on the TSCA Inventory, must provide a premanufacture notice (PMN) or an exemption application to the agency at least 90 days prior to commencing manufacture of that chemical.

The agency regularly adds new chemical substances that have completed new chemical review requirements pursuant to TSCA section 5(a) and that have been manufactured or processed for a non-exempt commercial purpose. EPA maintains the TSCA Inventory as the authoritative list of all the chemical substances reported to the agency for inclusion on the Inventory.

Chemicals on and not on the Inventory

Chemicals substances on the TSCA Inventory include:

• Organics;
• Inorganics;
• Polymers; and
• Chemical substances of unknown or variable composition, complex reaction products, and biological materials (UVCBs).

Chemical substances not on the Inventory are those with uses not regulated under TSCA. The use of these chemical substances is governed by other U.S. statutes on, for example:

• Pesticides,
• Foods and food additives,
• Drugs,
• Cosmetics,
• Tobacco and tobacco products,
• Nuclear materials, and
• Munitions.

For purposes of regulation under TSCA, if a chemical is on the Inventory, the substance is considered an “existing” chemical substance in U.S. commerce. Any chemical that is not on the Inventory is considered a “new chemical substance.” In addition to defining whether a specific substance is “new” or “existing,” the Inventory also contains “flags” for those existing chemical substances that are subject to manufacturing or use restrictions.

Completeness, accuracy, and legal standing

EPA’s compilation of the public TSCA Inventory information is updated twice a year to include new and corrected TSCA Inventory chemical listings. However, it contains none of the chemical identities claimed as confidential. Thus, it is not as complete nor current as the information contained in EPA’s TSCA Master Inventory File, which includes the chemical identities claimed as confidential and is updated continuously as new and corrected information is received by EPA.

Consequently, for the purposes of TSCA compliance, the TSCA Master Inventory File maintained by EPA’s Office of Pollution Prevention and Toxics is the only complete and accurate source that can provide authoritative and conclusive information about which chemical substances are currently included in the TSCA Inventory.

Accessing the Inventory

As part of EPA’s commitment to strengthen the management of chemicals and increase information on chemicals, the agency provides free access to the non-confidential portion of the TSCA Inventory online.

Determining if a chemical is on the Inventory is a critical step before beginning to manufacture (which includes importing) a chemical substance. TSCA Section 5 requires anyone who plans to manufacture a new chemical substance for a non-exempt commercial purpose to provide EPA with a premanufacture notice (PMN) at least 90 days before initiating the activity.

Submitting notices of bona fide intent to manufacture

Someone with a valid commercial need for EPA 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.

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.

The e-PMN software enables manufacturers (including importers) of TSCA chemical substances to use the Internet, through EPA’s Central Data Exchange (CDX), to submit TSCA section 5 notices to the agency. These notices include the bona fide notices.

Applicable laws & regulations

TSCA Section 2607(b) — Inventory

40 CFR 720 — Premanufacture notification

40 CFR 723 —Premanufacture notification exemptions

Related definitions

Chemical substance means any organic or inorganic substance of a particular molecular identity, including any combination of these substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any element or uncombined radical.

Inventory means the list of chemical substances manufactured or processed in the U.S. that EPA compiled and keeps current under section 8(b) of TSCA.

Manufacture means to produce or manufacture in the U.S. or import into the customs territory of the U.S.

New chemical substance means any chemical substance which is not included on the Inventory.

Process means the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce: (1) in the same form or physical state as, or in a different form or physical state from, that in which it was received by the person so preparing such substance or mixture; or (2) as part of a mixture or article containing the chemical substance or mixture.

Keys to remember

EPA must compile and keep current a listing of chemical substances manufactured, imported, and processed for commercial purposes in the U.S. EPA keeps a public TSCA Inventory (with non-confidential chemical identities) and a TSCA Master Inventory File (with both non-confidential and confidential chemical identities).

Anyone who plans to manufacture a new chemical substance (a chemical not on the Inventory) for a non-exempt commercial purpose must provide EPA with a PMN at least 90 days before initiating the activity. To verify if a substance is on the Inventory, a person with a valid commercial need can submit a bona fide notice to obtain a written determination from EPA.

Real world example

EPA provides a Microsoft® Access version and a generic comma-delimited “CSV” text version of the non-confidential TSCA Inventory for users to download. If you don’t have Microsoft Access, use the CSV file. The non-confidential portion of the TSCA Inventory can be searched or sorted in different ways:

• Use a basic “find” search function and type in a part of a chemical name or CAS Registry Number.
• You may also be able to do different or more complex searches or sorts (see your own software help system or your local computer support personnel for additional instructions).

Note that special flags are used throughout the TSCA Inventory to identify those substances on the Inventory that are the subject of an EPA rule or order promulgated under TSCA, as well as to indicate types of full or partial exemptions from TSCA reporting requirements. For further details see EPA’s How to Access the TSCA Inventory webpage.