Date: Jan 06, 2021
On January 5, 2021, the U.S. Environmental Protection Agency (EPA) released the pre-publication version of a final rule announcing the reopening of the reporting period under the Toxic Substances Control Act (TSCA) (15 U.S.C. § 2601 et seq.) “Active-Inactive” rule. This will allow companies to remedy any reporting errors that may have earlier been made under the rule pertaining to confidential business information (CBI) claims for specific chemical identities of substances listed on the TSCA Chemical Substance Inventory (Inventory).
TSCA Inventory Active-Inactive Rule and CBI Claims
The TSCA Active-Inactive Rule was published in 2017 and required U.S. manufacturers and importers to submit reports (Notice of Activity “Form As”) identifying chemicals that were manufactured, imported, or processed for non-exempt commercial purposes in the U.S. between June 21, 2006 and June 21, 2016. These reports allowed EPA to divide chemicals on the TSCA Inventory into “active” chemicals and “inactive” chemicals.
The rule also provided manufacturers and importers the opportunity to indicate if they sought to maintain existing CBI claims for chemicals that appeared on the confidential portion of the Inventory. In particular, the Form A allowed companies to identify if they were seeking to maintain an existing claim of confidentiality for the specific chemical identity of a confidential chemical, identified by Accession number. If multiple companies reported for the same chemical, and some companies sought to maintain the existing CBI claim for chemical identity, but even one company did not (by failing to check the appropriate box), EPA’s position has been and is that the chemical is publicly known to be in U.S. commerce and, therefore, planned to make the chemical identity public.
Re-Opening of Reporting Period for CBI Corrections
In May 2020, the Agency published an interim list of Accession numbers for confidential chemicals that it planned to make public due to responses received in NOA Form As. Since that time, EPA has been informed by submitters about confusion regarding the requirements of the Active-Inactive reporting rule, misunderstandings about the rule’s exemptions from reporting, the lack of supplier or customer coordination on reporting, the lack of coordination between companies reporting for the same confidential chemical, and reporting errors. EPA is also concerned about the potential consequences, including substantial financial and competitive harm, that companies fear they will face if EPA were to disclose the chemical identities of CBI substances.
The rule, therefore, will reopen the reporting period for 60 days to give companies the opportunity to submit, amend, or withdraw NOA Form A “active” notifications solely to make any corrections to confidentiality claims and substantiations. EPA clarifies that entities who reported a chemical that is on the public portion of the TSCA Inventory should not use this re-opened reporting window. Companies may also use the re-opened reporting period to provide the required CBI substantiations.
The reporting period will begin 30 days after the rule is published in the Federal Register. The reporting deadline for submissions, amendments, or withdrawals of NOA Form As, and for submission of accompanying CBI substantiations, will be 60 days after that date (90 days after the date of the rule’s publication in the Federal Register).
For more information, please contact Keller and Heckman’s Chemical Control Practice Group.