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FAQs about TSCA Chemical Substances Control Inventory

Posted Date:2018/9/19

What is the TSCA Chemical Substances Control Inventory?

Section 8 (b) of the Toxic Substances Control Act (TSCA) requires EPA to compile, keep current and publish a list of each chemical substance that is manufactured or processed, including imports, in the United States 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 United States.

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 has continued to grow since then, and now lists about 85,000 chemicals.

As part of EPA’s commitment to strengthen the management of chemicals and increase information on chemicals, the Agency provides free access to the inventory online.

Inventory basics: How TSCA defines “chemical substance” 

TSCA defines a “chemical substance” as 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.

Chemicals substances on the 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, or 

· Munitions. 

What does it mean for a chemical to be on the Inventory?

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.

Determining if a chemical is on the Inventory is a critical step before beginning to manufacture (which includes importing) a chemical substance. Section 5 of TSCA 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.

How do I find out if a substance is on the Inventory?

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.

In a bona fide notice, a submitter must provide specific chemical identification data including:

· Chemical Abstracts Index name. Proper CA Index names can be obtained from the Chemical Abstracts Service's Inventory Expert Service;

· Informmationabout 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 and, if the Agency believes that the submitter has demonstrated a genuine intent to manufacture or import, search the full TSCA Inventory master file and provide a written determination to the submitter on the TSCA Inventory status for the chemical substance.

How are chemicals added to the Inventory?

After 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 calendar days of the date the substance is first manufactured or imported for nonexempt commercial purposes.

Once a complete NOC is received by EPA, the reported substance is considered to be on the Inventory and becomes an “existing chemical.” The Agency receives approximately 400 NOCs each year, thus the TSCA Inventory changes almost daily.

Substances reported through exemption submissions and exempt uses that are not subject to reporting do not require an NOC and are not added to the Inventory. Examples include:

· Low Volume Exemptions (LVEs)

· Low Release/Low Exposure Exemptions (LoREXs)

· Test Market Exemptions (TMEs)

· Substances used for research and development

· Polymers that meet the 1995 Polymer Exemption Rule Amendments