• 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 the CBI 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.

Expiring CBI Claims

The Frank R. Lautenberg Chemical Safety for the 21st Century Act (which became law in June 2016) set an automatic 10-year expiration for most CBI claims made under TSCA. The first round of expiring claims starts in June 2026. he list covers CBI claims that expire from June 22, 2026, to July 31, 2026.EPA allows businesses to request extensions of CBI protection for up to another 10 years.

EPA will notify businesses of expiring CBI claims directly through the Central Data Exchange (CDX). The agency will also release public lists of upcoming expiring CBI claims monthly on the “CBI Claim Expiration” webpage. The agency encourages businesses to review the lists to verify whether any of their claims are included.

Businesses seeking to extend a CBI claim beyond its expiration date must submit an extension request at least 30 days before the claim expires using the newly launched TSCA Section 14(e) CBI Claim Extension Request application in EPA’s CDX. Here’s the general process:

• EPA notifies the business of an expiring CBI claim directly through CDX and via the public lists on the “CBI Claim Expiration” webpage.
• The business submits a request for extension through EPA’s CDX at least 30 days before the CBI claim expires. Requests must comply with the substantiation requirements at 40 CFR 703.5(a) and (b).
• EPA reviews the submission and either grants or denies the request.

If EPA approves the extension request, the information in the CBI claim will remain protected for up to another 10 years.

If EPA denies the extension request, the agency can publicize the information in the claim 30 days after notifying the submitter in CDX. Further, if a business doesn’t submit an extension request at least 30 days before the expiration date, EPA may publicize the information without notifying the submitter.