The EPA has released what it describes as the first update of the Toxic Substances Control Act (TSCA) Inventory in 40 years. The update indicates that 47 percent of the 86,228 chemicals listed on the Inventory are “active,” which means they have been manufactured, processed, or imported for a nonexempt commercial purpose during the 10-year “lookback” period ending on June 21, 2016, the enactment date of the 2016 TSCA amendments.

Determining if a chemical is on the Inventory is a critical step before beginning to manufacture, process, or import a chemical substance. 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.” Section 5 of TSCA requires that anyone who plans to manufacture a new chemical substance for a nonexempt commercial purpose must provide the EPA with a Premanufacture Notice (PMN) at least 90 days before initiating the activity.

Existing but not in commerce

The TSCA Inventory has long been considered a bloated resource, loaded with chemicals that are no longer active and in commerce. Under the amendments, Section 8(b)(4)(A) gave the EPA 1 year to require that manufacturers notify the Agency about which of their Inventory chemicals are active; a chemical for which no notice was received would be considered inactive. The EPA spelled out the electronic notification requirements in what has been termed the TSCA Reset Rule (August 11, 2017, Federal Register (FR)). The reset rule also established procedures for “forward-looking” electronic notification of chemical substances on the TSCA Inventory, which are designated as inactive, if and when the manufacturing or processing of such chemical substances for nonexempt commercial purposes is expected to resume. On receiving a forward-looking notification, the EPA changes the designation of the pertinent chemical substance on the TSCA Inventory from inactive to active.

Under the reset rule, companies had about 13 months to provide notices. According to the Agency, more than 90,000 responses were received.

Public and CBI inventories

Under TSCA, the EPA also develops two TSCA Inventories—one version the public may access at any time and one version that is not accessible to the public because the manufacturers claim the information they provided to the Agency constitutes trade secrets. The TSCA amendments indicate that the EPA must develop criteria manufacturers must meet to substantiate their trade secret or confidential business information (CBI) claims. The Agency says it is in the process of developing a rule on how CBI claims must be substantiated. Also, the EPA notes that more than 80 percent of Inventory chemicals in commerce are not CBI.

According to the EPA, the updated Inventory will enable the Agency to focus its new TSCA risk evaluation responsibilities on chemicals that are actually in commerce.