Final Rule; Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory (Notice of Activity Form As) (Final Rule)

The Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, required 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, the TSCA Inventory Notification (Active-Inactive) Requirements Rule (“2017 Active-Inactive Rule”), requiring industry reporting of chemicals manufactured (including imported) or processed in the U.S. over the past 10 years, ending on June 21, 2016. This retrospective reporting was used to identify which chemical substances on the TSCA Inventory are active in U.S. commerce and will help inform the prioritization of chemicals for risk evaluation. The retrospective reporting period for manufacturers (includes importers) ended on February 7, 2018, and the retrospective reporting period for processors ended on October 5, 2018. 82 FR 37520 (8/11/17) https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0426-0070. Included in the 2017 Active-Inactive Rule were provisions for the submission of confidential business information (CBI) and requests to maintain existing CBI claims for the specific chemical identities of chemical substances. Submitters were required to substantiate all CBI claims made in that collection except for specific chemical identity CBI claims asserted during retrospective reporting—which they had an option to voluntarily substantiate at the time of filing their report. This regulatory action, the Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory (RIN 2070-AK21), is a companion rule to the 2017 Active-Inactive Rule. TSCA section 8(b)(4)(C) requires that “[n]ot later than 1 year after the date on which the Administrator compiles the initial list of active substances [pursuant to the 2017 Active-Inactive Rule], the Administrator shall promulgate a rule that establishes a plan to review all claims to protect the specific chemical identities of chemical substances on the confidential portion of the list” that were asserted during retrospective reporting under the 2017 Active-Inactive Rule. The statute at section 8(b)(4)(D) prescribes the requirements of the plan. TSCA section 8(b)(4)(E) provides the timeframe for the reviews of CBI claims for specific chemical identities, extension possibilities and process, and requirements for providing updates on the Agency’s progress. The data elements covered under the rule are chemical substance identities claimed as CBI in commercial activity notices, or Notices of Activity (NOAs), submitted as part of the 2017 Active-Inactive Rule collection. In many instances the CBI claims for specific chemical identities were voluntarily substantiated through the 2017 Active-Inactive Rule collection. This ICR covers the burden for those who submitted NOAs Form A (retrospective commercial activity notice) and requested to maintain an existing CBI claim for a specific chemical identity for the 2017 Active-Inactive Rule. Additional burden from this regulatory action that is related to NOAs Form B submissions (forward-looking commercial activity notices), which occur on an annual ongoing basis, are addressed in a separate ICR for the 2017 Active-Inactive Rule.

The latest form for Final Rule; Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory (Notice of Activity Form As) (Final Rule) expires 2023-12-31 and can be found here.