On June 1, 2023, the EPA published a final rule to modernize the reporting and review processes for Confidential Business Information (CBI) under the TSCA. This rule increases transparency conforms to the 2016 amendments to the TSCA and updates the requirements for CBI. After the rule is published in the Federal Register, the requirements take effect 60 days later.

The following amendments are included in the final rule, along with clarifications to make sure that the regulations clearly state when the EPA is required by law to request substantiation and reject claims, leading to more details being available to the spotlight. A clearer definition of a CBI claim's scope and a restriction on the data the submitter deems confidential are the results of the changes. The final rule also limits the information that can be claimed as CBI in health and safety studies. A clause that addresses excessively broad CBI claims in TSCA submissions that are available to the public, particularly when it comes to information about health and safety, and that outlines a procedure for the submitter to quickly fix those problems early in the CBI review. These modifications should clear up any doubts regarding the applicability or veracity of the claims.

Expanded electronic reporting requirements as well as uniform standards for releasing publicly accessible copies of specific documents, such as scientific studies, would speed up the public's access to more data. Required notices of CBI claims must be delivered to submitters more quickly thanks to requirements for electronic communication and maintaining accurate contact information. Clarifying language on how the EPA will handle information obtained under other statutes but used in the TSCA program that also has valid CBI claims under those statutes. This will ensure consistency with the Agency's obligation to make information publicly available when legally permitted.

A standard set of substantiation questions used to support a CBI claim is included in clear, uniform guidance on the requirements for making and maintaining CBI claims. Requirements for nearly all CBI claims to be submitted electronically, as well as improvements to reporting tools to prevent or mitigate common procedural errors. A new section of the TSCA regulation codifies and harmonizes how TSCA CBI claims must be made and supported. When submitting health and safety information, submitters must use an appropriate Organization for Economic Cooperation and Development harmonized template, if one is available.

Reference: Final Rule: Requirements for Confidential Business Information Claims under TSCA | US EPA


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