• TSCA requires EPA to designate chemical substances on the TSCA Chemical Substance Inventory as either “active” or “inactive” in U.S. commerce.
• TSCA requires EPA to establish a rule on CBI claims for specific chemical identities for chemicals reported as “active” in response to the TSCA Inventory Notification Requirements Rule.

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 Environmental Protection Agency (EPA) subsequently compiled and published the Toxic Substances Control Act (TSCA) Inventory in 1979. A second version was published in 1982.

Today, the TSCA Inventory is updated every six months, if possible. It is noteworthy that three actions in modern history have shaped the latest TSCA Inventory. They include the:

• TSCA Inventory Notification (Active-Inactive) rule (also called the Inventory Reset rule), August 11, 2017;
• Procedures for Review of Confidential Business Information (CBI) Claims for the Identity of Chemicals on the Toxic Substances Control Act Inventory rule, March 6, 2020;
• EPA Extends Notification Deadline for Updates to Confidential Status of Chemicals on the TSCA Inventory; EPA announcement, May 14, 2021; and
• CBI Claims Under the Toxic Substances Control Act (TSCA) final rule, June 7, 2023.

Inventory reset rule

TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, requires EPA to designate chemical substances on the TSCA Chemical Substance Inventory as either “active” or “inactive” in U.S. commerce.

To accomplish that, EPA finalized a rule requiring industry reporting of chemicals manufactured (including imported) or processed in the U.S. over a 10-year period ending on June 21, 2016. This reporting was completed on October 5, 2018, and was used to identify chemical substances on the TSCA Inventory as active or inactive in U.S. commerce.

EPA includes the active and inactive designations on the TSCA Inventory and as part of its regular publications of the Inventory. Starting August 5, 2019, manufacturers and processors were required to notify EPA before reintroducing inactive substances into U.S. commerce. Manufacturers and processors can notify EPA via a Notice of Activity Form B, found in EPA's Central Data Exchange (CDX). Upon receiving such notification, EPA will change the commercial activity designation of inactive substances to active.

On October 13, 2021, EPA remarked that the Inventory contained 86,607 chemicals of which 41,953 were active in U.S. commerce. Note that the August 2023 update of the Inventory contains 86,718 chemicals, of which 42,242 are active.

Review of CBI claims rule

Section 8(b) of TSCA requires EPA to establish a rule on confidential business information (CBI) claims for specific chemical identities for chemicals reported as “active” in U.S. commerce in response to the TSCA Inventory Notification (Active-Inactive) Requirements Rule.

On March 6, 2020, EPA finalized a rule on the procedures for companies to substantiate their CBI claims for the specific chemical identities of substances on the TSCA inventory, as well as the plan for how the agency will review the claims, the timeframes for EPA to complete reviews, and the annual posting of results.

The final rule also included two additional questions on reverse engineering that manufacturers and processors will be required to answer to substantiate their specific chemical identity CBI claims. These two questions were added as part of the agency's response to a court-ordered remand of part of the TSCA Inventory Notification (Active-Inactive) Requirements Rule. The rule amended existing sections of 40 CFR 710 and added 40 CFR 710 Subpart C.

Updates to confidential status of chemicals

In April 2021, EPA posted a list of 390 chemicals by accession number expected to lose their confidential chemical identity status and move to the public portion of the TSCA Inventory and gave stakeholders a deadline of May 14, 2021, to notify the agency of any errors on the list. In response to industry stakeholder requests for additional time to review this list, EPA extended the notification deadline to June 30, 2021.

EPA planned to declassify the specific identities of these chemicals because they were reported as non-confidential by one or more manufacturers during the 2012, 2016, and/or 2020 Chemical Data Reporting (CDR) reporting periods — meaning that at least one manufacturer did not request that each of these chemical identities be kept confidential, effectively saying it is not a secret that the chemical is in U.S commerce.

On October 13, 2021, EPA announced that the agency updated the confidential status of 377 chemical identities and would include these chemical identities on the winter 2022 TSCA Inventory. The 377 declassified specific chemical identities were made available with the October 13, 2021, announcement.

Confidential business information claims under TSCA final rule

EPA finalized new and amended requirements on June 7, 2023, concerning the assertion and treatment of CBI claims for information reported to or otherwise obtained by EPA under TSCA. The rule took effect August 7, 2023. Amendments to TSCA in 2016 included many new provisions concerning the assertion, agency review, and treatment of confidentiality claims. This rule:

• Finalized procedures for submitting such claims in TSCA submissions;
• Addressed issues such as substantiation requirements, exemptions, electronic reporting enhancements (including expanding electronic reporting requirements), maintenance or withdrawal of confidentiality claims, and provisions in current rules that are inconsistent with amended TSCA; and
• Addressed EPA procedures for reviewing and communicating with TSCA submitters about confidentiality claims.