On March 6, 2020 EPA published the final rule “Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory” (85 FR 13062). The rule becomes effective May 5, 2020. The actions mandated by the proposed rule were summarized in our February 24, 2020 alert. Publication of the final rule establishes the deadlines for submission of the required updates to existing substantiations.
CBI Substantiation Document Type Deadline
Active/Inactive Rule NOA Form A November 1, 2020
Active/Inactive Rule NOA Form B June 4, 2020
Others since 2015 (e.g., CDR, NOC) November 1, 2020
In addition, EPA provided more background on the “reverse engineering” question. The finalized version asks more directly whether the specific chemical identity can be readily discovered by analysis of the substance (e.g., product, effluent, or emission) in light of existing technologies and any associated costs, difficulties, or limitations. The answer to this question must be thorough and defensible.
As mentioned in the earlier alert regarding this rule, it is essential to review previous substantiations to assure their validity and avoid the risk of CBI protection denial by the Agency.