Making CBI Claims in TSCA Submissions

Under section 14(a) of the Toxic Substances Control Act (TSCA), submitters may claim information submitted to 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).

• Read the Federal Register Notice announcing EPA’s final CBI procedures rule.

On this page:

• Examples of information that may not be protected as CBI
• How to make CBI claims in TSCA submissions
• Electronic submissions of CBI required
• EPA Contacts

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 a 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.

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 following certification statement 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).  Read EPA’s guidance for the creating generic names.

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.

Electronic submissions of CBI required

Almost all TSCA submissions are required by regulation to be submitted electronically.  View more information about electronic reporting requirements for information under TSCA. 40 CFR 703.5(f).

TSCA electronic reporting tools are available in the Chemical Safety and Pesticide Programs (CSPP) portion of EPA’s Central Data Exchange (CDX). The electronic reporting applications for many TSCA submission types are based on fillable forms where each data element is entered individually. In most cases, information that may be claimed as CBI includes a checkbox for designating the information as CBI adjacent to the field where the information is to be entered.

In cases in which the electronic reporting application does not support making a CBI claim adjacent to where the information is entered (for example, if a submission includes document attachments), the submitter is responsible for indicating what information is being claimed as CBI. For documents created outside of the CDX reporting application that include CBI claims, both the complete document (with information claimed as CBI shown) and a sanitized version (with CBI redacted or otherwise masked) must be attached to the submission.

For electronic submissions, the above certification statement is incorporated into the reporting application. The official making the submission will be prompted to agree to the certification statement prior to being able to complete the submission.

If specific chemical identity is claimed as CBI, a structurally descriptive generic name must also be provided. Electronic reporting applications provide a field for inputting a structurally descriptive generic name for all submission types. Substantiation questions are also incorporated into the reporting applications.

EPA Contact

For more information on making CBI Claims in TSCA submissions, please contact:

• Jessica Barkas, 202-250-8880, [email protected]
• Nick Lillo, 202-564-4741, [email protected]