Last week, the U.S. Environmental Protection Agency announced that it was releasing a list of 390 chemicals that the agency expected to lose their confidential status and move to the public portion of the TSCA Inventory. EPA stated that submitters had reported that the specific identities of these chemicals were not confidential in their Chemical Data Rule (CDR) reporting from the 2012, 2016, and/or 2020 reporting periods. EPA advised that interested stakeholders should ask questions and share any concerns about this CBI release with EPA staff by no later than May 14, 2021.
Even though it appears that this release of CBI will not be contested, EPA’s announcement is a good reminder that submitters must ensure that they meet the requirements of TSCA to receive CBI protection. If EPA determines that you failed to substantiate your CBI claim, then your company’s only recourse is to file a lawsuit in federal district court before the date on which EPA plans to disclose the information. TSCA prohibits EPA from disclosing this information pending judicial review of the determination.
To avoid litigation costs and the risk of losing CBI, it pays to invest now to ensure that you are meeting the TSCA substantiation requirements. For more information about confidentiality claims under TSCA, please see Wiley’s prior Alert.