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 interpretation of revised TSCA requiring up front substantiation of CBI claims.
- Read EPA’s guidance regarding the application of section 14(c)(2) to certain types of commonly submitted information.
On this page:
- Examples of information that may not be protected as CBI
- How to make CBI claims in TSCA submissions
- Considerations for electronic submissions of CBI
- Considerations for paper submissions of CBI
- 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.
There are several procedural requirements that must be followed when asserting CBI claims in TSCA submissions.
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.
If specific chemical identity is claimed as CBI, a structurally descriptive generic name must also be provided. Read EPA’s guidance for the creation and approval of generic names.
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
- My company has taken reasonable measures to protect the confidentiality of the information;
- I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;
- 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
- 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.
Most TSCA submissions are required by regulation to be submitted electronically. View more information about electronic reporting requirements for information under TSCA.
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) generally 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 are being modified to provide a field for inputting a structurally descriptive generic name for all submission types.
If information in an electronic submission is claimed as CBI, the official making the submission will be prompted to upload a document substantiating the CBI claims or providing a reason why the submitter believes no substantiation is required under section 14(c)(2).
While most TSCA submissions are required by regulation to be submitted electronically, several submission types may still be submitted on paper. The general process for making paper submissions has not changed and submitters should follow the instructions for submitting found in the applicable regulations and Agency issued guidance. The recent revisions to TSCA, affecting what is required when claiming information as CBI, apply to submissions made on paper.
A paper submission with CBI claims must include the certification statement set forth above. If specific chemical identity is claimed as CBI, a structurally descriptive generic name must also be provided.
For more information on making CBI Claims in TSCA submissions, please contact:
- Scott Sherlock, 202-564-8257, firstname.lastname@example.org
- Jessica Barkas, 202-250-8880, email@example.com