Review of Confidential Business Information Claims under TSCA

Basic Information on Effort to Review Claims of Confidential Business Information (CBI)

In 2010, EPA initiated a program to review and where appropriate challenge confidentiality claims for chemical identity in health and safety studies. The purpose of EPA's action was to support both legitimate CBI claims and to protect the public’s right-to-know about potential risks posed by widely-used chemicals. 

Read about EPA's policy change on what information is eligible to be claimed at CBI under TSCA.

EPA's FY 2011-2015 EPA Strategic Plan included a measure to review, and challenge where appropriate, more than 22,000 existing TSCA cases with CBI claims for chemical identity, potentially containing health and safety studies. 

In addition to reviewing existing cases, all new cases containing health and safety studies submitted under TSCA that claim the chemical identity as CBI, and are chemicals in commerce, are being reviewed upon receipt to determine if the claims are appropriate.

EPA may notify companies that information is not eligible for CBI, and in those instances where the company will not voluntarily relinquish the claims, EPA may initiate administrative actions under 40 CFR part 2.

Where EPA determines that the information is not eligible for confidential treatment under the law, the agency notifies companies of the determination and EPA makes the information public on the 31st day after receiving the determination unless the company challenges the disclosure in federal court.

In some instances, the information submitters have proactively reviewed and released materials where the CBI claims could not be justified.  In other instances, the claims were released as a result of contact and action by EPA.