• There are several procedural requirements that must be followed when asserting CBI claims in TSCA submissions.
• If specific chemical identity is claimed as CBI, a structurally descriptive generic name must also be provided.

Under section 14(a) of the Toxic Substances Control Act (TSCA), submitters may claim information submitted to the Environmental Protection Agency (EPA) under TSCA as confidential business information (CBI). CBI claims must be asserted and substantiated concurrently with the submission of the information, except for those types of information exempt under TSCA section 14(c)(2).

Examples of information that may not be protected as CBI

TSCA section 14(b) identifies certain information that may not be protected as CBI, including:

• Health and safety studies and information from health and safety studies where the chemical or mixture has been offered for commercial distribution or for which testing is required under TSCA section 4 or notification is required under TSCA section 5. However, process information and portions of mixture information may be protected;
• Any general information describing manufacturing volumes, expressed as specific aggregated volumes or, if the EPA Administrator determines that disclosure of specific aggregated volumes would reveal confidential information, expressed in ranges; and
• A general description of a process used in the manufacture or processing and industrial, commercial, or consumer functions and uses of a chemical substance, mixture, or article containing a chemical substance or mixture, including information specific to an industry or industry sector that customarily would be shared with the general public or within an industry or industry sector.

How to make CBI claims in TSCA submissions

There are several procedural requirements that must be followed when asserting CBI claims in TSCA submissions. These are described in detail in 40 CFR 703.

TSCA submitters are solely responsible for ensuring that all the requirements for claiming information as CBI are met at the time the information is submitted to EPA. The procedural requirements for making a CBI claim include:

• The required certification statements;
• Information claimed as CBI is clearly identified;
• Substantiation of CBI claims for information that is not exempt from substantiation under section 14(c)(2);
• Sanitized copy provided as required; and
• A structurally descriptive generic name, if a CBI claim is for a specific chemical identity.

The authorized official submitting CBI claims must make several assertions as well as certify that information submitted to substantiate a CBI claim is true and correct, as required by sections 14(c)(1)(B) and 14(c)(5) of TSCA.

EPA has combined these requirements into the certification statement (below) that can be used to satisfy these requirements. See 40 CFR 703.5(a). If specific chemical identity is claimed as CBI, a structurally descriptive generic name must also be provided. See 40 CFR 703.5(d).

Certification statement for CBI claims

I hereby certify to the best of my knowledge and belief that all information entered on this form is complete and accurate. I further certify that, pursuant to 15 U.S.C. 2613(c), for all claims for confidentiality made with this submission, all information submitted to substantiate such claims is true and correct, and that it is true and correct that

1. My company has taken reasonable measures to protect the confidentiality of the information;
2. I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;
3. I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and
4. I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.

Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. 1001.