• TSCA imposes requirements that submitters must meet when claiming information as CBI.

Because information that the Environmental Protection Agency (EPA) obtains may contain material that, if disclosed, would harm commercial interests, the Toxic Substances Control Act (TSCA) prohibits the disclosure of submitted information for which the submitter has claimed and justified the need for confidentiality. EPA regulations establish procedures to protect such confidential business information (CBI) from public disclosure.

Overview

Some of the information chemical manufacturers and processors submit to EPA under TSCA is proprietary. CBI is broadly defined as proprietary information, considered confidential to the submitter, the release of which would cause substantial business injury to the owner. Companies generally make CBI claims for confidential proprietary information believed to give other companies an advantage in the marketplace, such as details of their manufacturing processes and formulas.

To balance the objectives of protecting sensitive or proprietary information from public disclosure and maintaining the public’s right of access to information about EPA’s activities, section 14 of TSCA protects information from disclosure under certain conditions. Specifically, TSCA builds upon protections from disclosure set forth in the Freedom of Information Act (FOIA).

FOIA generally requires federal agencies to disclose information requested by any person unless the information falls under one of nine exemptions. Section 14 of TSCA requires EPA to withhold from disclosure information that meets the criteria under FOIA Exemption 4 for which a confidentiality claim has been properly asserted. FOIA Exemption 4 protects “trade secrets and commercial or financial information obtained from a person and privileged or confidential.” Knowing and willful disclosure of such information is subject to a criminal penalty under TSCA.

TSCA requires the agency to review and make determinations regarding the validity of claims based on the criteria in the statute and regulations. TSCA also imposes requirements that submitters must meet when claiming information as CBI. Some of these requirements include:

• Assertions that the submitter must make;
• Substantiation of all CBI claims, except for those on information exempt from substantiation under TSCA section 14(c)(2); and
• A structurally descriptive generic name, if a CBI claim is for a specific chemical identity.

EPA may also review and make determinations on CBI claims in other circumstances, including when information that is claimed as CBI is responsive to a request under FOIA.