EPA finalizes rule for substantiating chemical identity CBI claims for active chemicals on the TSCA inventory
The Environmental Protection Agency (EPA) has published the final rule outlining the steps companies must take to substantiate confidential business information (CBI) claims for chemical substances listed on the confidential portion of the TSCA inventory.
Companies that submitted a Notice of Activity Form A under the Active-Inactive rule and claimed the specific chemical identity as confidential will have 180 days from the effective date of the CBI rule (60 days from the date of publication in the Federal Register) to amend voluntary substantiations or file new ones consistent with the requirements set forth in the rule. Companies that provided upfront CBI substantiation at the time of submission of the NOA Form A, will only be required to amend their submissions to provide responses the two new questions relevant to reverse engineering.
Companies that have already substantiated CBI claims for specific chemical identities in other submissions made to EPA less than five years before the substantiation deadline set forth in the rule are partially exempt. Examples of other submissions include 2016 CDR or relevant Notices of Commencement (NOCs) if the prior substantiation contains information that addresses all substantiation questions included in the rule. Those who wish to use this exemption must report to EPA the submission date, submission type, and the case number, transaction ID, or equivalent identifier for the previous submission that contained the relevant substantiation.
Moving forward all amendments, updates and new filings for CBI substantiations must be done electronically though EPA’s Central Data Exchange.
How TSG can help
Our consultants are well versed in TSCA regulations and can assist clients in all aspects of compliance. TSG’s consultants prepare new chemical notifications, perform TSCA compliance audits and trainings, as well as assist with the substantiation of CBI claims. Contact us today to learn how we can assist you: [email protected].