CBI Claim Expiration

On this page:

• Introduction
• Is my CBI Claim Expiring?
• When does my CBI Claim Expire?
• Notification of Expiring Claims
• Requesting and Substantiating an Extension
• When is the Request for an Extension Due?
• EPA Review of Requests for Extensions
• Frequently Asked Questions (FAQs)

Introduction

TSCA section 14(e) (26 USC 2613) limits the duration of most confidential business information (CBI) claims to 10 years from the date of the original submission, unless the submitting company requests and EPA approves an extension. Without an approved extension, EPA may make the claimed information public without further notice. The first group of CBI claims submitted by companies after the Lautenberg Act was signed into law in 2016 will expire in June 2026 unless requests for extension for those claims are submitted and substantiated within established timeframes. 

To reassert an expiring CBI claim for up to an additional 10 years, a company must submit a request for an extension that substantiates the need for continued protection of the information from disclosure. The information below describes which CBI claims require an extension, how EPA will notify submitters of expiring CBI claims, the process for requesting an extension, and the EPA review process.

Is my CBI Claim Expiring?

Confidentiality claims for most information submitted under TSCA expire 10 years after the date on which the claim was asserted. That means most confidentiality claims expire 10 years from the date of the TSCA filing in which information was submitted to EPA.

While claims for most information submitted under TSCA and claimed as confidential are subject to expiration, certain information identified as exempt from substantiation and EPA review under TSCA section 14(c)(2) is also exempt from expiration under TSCA section 14(e)(1)(B). Broadly, this includes the following categories of information:

1. Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article;
2. Marketing and sales information;
3. Information identifying a supplier or customer;
4. In the case of a mixture, details of the full composition of the mixture and the respective percentages of constituents;
5. Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or article;
6. Specific production or import volumes of the manufacturer or processor; and,
7. Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of the chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service (CAS) number, and other information that would identify the specific chemical substance, if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under TSCA  section 5.

Information exempt from substantiation requirements is described in EPA’s regulations at 40 CFR Part 703.5(b)(5)(ii) and (ii). In addition, individual TSCA reporting applications and specific reporting rules generally indicate which information elements are exempt or may be exempt from upfront substantiation requirements (see, e.g. 40 CFR 711.30(a)(3)). 

If a submitter is uncertain as to whether particular information is covered by one of the exemptions (i.e., neither the reporting form nor applicable reporting rule list specifically indicate that the information is exempt under section 14(c)(2)) but would like the information to remain as confidential, they should submit a request for extension, substantiating the need for an additional period of protection. If EPA does not receive a request for extension and the information is not clearly subject to one of the listed exemptions, EPA would conclude that the submitter is allowing the confidentiality claim to expire, and the information could be made available to the public without notice to the submitter.

When does my CBI Claim Expire?

Expiration dates for all non-exempt, non-chemical identity claims are set 10 years from the date the claim was asserted, normally 10 years from the date information was submitted to EPA. CBI claims for the specific chemical identity of a substance, however, are set 10 years from the submission date of the first approved CBI claim for that specific chemical identity made by any TSCA submitter after June 22, 2016 (see 83 FR 30168 (June 27, 2018)). This means that subsequent submitters for the same specific chemical identity may learn that the CBI claim applicable to their submission expires less than 10 years from the date of their actual submission. Expiration dates for chemical identities are available on the TSCA Chemical Inventory. Any company within an interest in maintaining the confidential status of a chemical substance with an expiring claim for specific chemical identity will be able to request an extension.

Notification of Expiring Claims

TSCA section 14(e) requires EPA to notify the submitter of an expiring CBI claim at least 60 days prior to expiration. To meet this requirement, EPA plans to publish on its website a list of TSCA submissions with CBI claims approaching the end of the 10-year period of protection. For confidentiality claims for specific chemical identities, submitters can consult the TSCA inventory to determine expiration dates for substances for which they have made TSCA submissions. These lists will be published no later than 60 days prior to the date the claim is to expire, beginning in spring 2026 and continuing thereafter. Please monitor this web page and other EPA communications for the publication of lists of submissions with expiring claims. 

In addition, EPA plans to transmit a direct notice to the original submitter of each CBI claim via the agency’s electronic document system, the Central Data Exchange (CDX). To receive timely notice, EPA strongly advises submitters to keep their company contact information updated in CDX. Submitters should take care to preserve their CDX passphrases to expedite access to their TSCA submissions. Companies with lapsed or inaccessible CDX accounts should re-establish that access by contacting the CDX help desk (helpdesk@epacdx.net) as soon as possible. 

EPA plans to communicate with stakeholders before, during, and after the CBI claim extension process through a variety of methods. Companies should monitor the Federal Register, relevant agency listservs, and this website for further information about expiring TSCA claims, the extension process, and specific instructions for submitting requests. 

Requesting and Substantiating an Extension

EPA expects that before their CBI claims are set to expire, companies will assess whether confidentiality is still necessary. Claims may be extended for up to an additional 10 years. Submitters must electronically submit their request for an extension using a new CDX application EPA is developing that is specific to extension requests. 

To extend an expiring CBI claim, companies must submit a timely request via the applicable CDX application to request an extension that substantiates the need to extend CBI protection. To be timely, companies must submit their request for an extension no later than 30 days before the CBI claim is set to expire. 

The specific requirements for substantiation are detailed in 40 CFR 703.5(a) and (b), which generally requires a supporting statement and certification of the following:

• The submitter has taken reasonable measures to protect the CBI;
• The CBI is not required to be disclosed under federal law;
• Disclosure of the CBI would cause substantial harm to the competitive position of the company;
• The CBI is not readily discoverable via reverse engineering.

When is the Request for an Extention Due?

Companies must submit their request for an extension no later than 30 days before the date that the CBI claim is set to expire. If EPA does not receive a timely request for an extension, the agency is no longer required to safeguard the information as CBI. See 15 USC2613(g)(2)(C)(iii)(ll). After that time, the information may be made public without further notice to the submitter.

EPA Review of Requests for Extensions

EPA will review each request for an extension and either grant or deny the request no later than the expiration date of the CBI claim. If approved, the confidential information will be protected from disclosure for up to an additional 10 years, unless the claim is later denied by EPA or withdrawn by the submitter.

If EPA denies an extension request, TSCA section 14(g)(2) requires that EPA notify the submitter in writing of the reasons for the denial at least 30 days prior to the intended disclosure of the information. EPA will make this notification via CDX, consistent with 40 CFR 703.5(h). 

Frequently Asked Questions

Q: How are expiration dates for TSCA confidentiality claims determined?

A: TSCA section 14(e) sets the expiration date for confidentiality claims made in TSCA submissions as 10 years from the date the claim is asserted. For most claims that means 10 years from the submission date of the TSCA filing in which information was submitted to EPA. Subsequent amendments to that initial submission do not establish a new expiration date for the information. 

For confidentiality claims for specific chemical identity, the expiration date is calculated based on 10 years from the first submission with a claim for the specific chemical identity of the substance received after the enactment of the TSCA amendments on June 22, 2016. Because more than one company can make submissions on the same chemical substance, but TSCA requires publishing an expiration date for each substance on the confidential portion of the TSCA inventory (TSCA section 8(b)(7)((C)(ii)), confidentiality claims for specific chemical identity are calculated using the first submission on that substance regardless of the submitting company. 

Later submissions made for the same substance that also claim the specific chemical identity do not reset or extend the expiration date. As such, submitters should consult the TSCA inventory to determine expiration dates for substances for which they have made TSCA submissions, even if those submissions are more recent than 10 years. 

Q: If EPA does not have the CDX reporting application ready or does not complete its review of my request to extend my CBI claims by the expiration date, will my information be released?

A: EPA expects to have the CDX tool in place prior to the time claims begin to expire. If there is a delay, EPA will provide notice of this delay and provide an estimated date of completion on this website (https://www.epa.gov/tsca-cbi). Should a delay occur, submitters should postpone sending extension requests until EPA provides notice that the CDX tool is available. Under TSCA section 14(g)(1)(D) (15 U.S.C. 2613(g)(1)(D)), EPA will not release any information subject to expiring claims until the notice and review requirements of section 14(e) are met. Similarly, if EPA does not complete its review of requests for extension by the expiration date, the information will continue to be protected until the review is complete and any applicable appeal period under section 14(g) has elapsed.

Q: Can a submitter request an extension of their confidentiality claims prior to receiving notice of impending expiration?

A: No, requests to extend should not be submitted until notification has been provided, either directly through CDX or through published lists of submissions or chemical substances with expiring claims. Also, EPA will only accept requests for extension submitted through the CDX reporting application, which will be available prior to the first claims expiring.

Q: What can a company do to prepare for expiring confidentiality claims?

A: EPA recommends that companies review their records of submissions made on or after June 22, 2016, to determine the submissions with CBI claims for which they might seek to extend the period of CBI protection. 

For claims relating to the specific chemical identity of chemical substances, EPA recommends reviewing the TSCA inventory (available at https://www.epa.gov/tsca-inventory/how-access-tsca-inventory) to determine the expiration date of those CBI claims. This information is contained in the column labeled “EXP”. 

EPA recommends that entities that submitted TSCA information beginning in 2016 should consider several issues well in advance of the end of the 10 year period of CBI claim protection: 

• CBI claim submitters should assess whether the CBI claims need to be renewed. 
• CBI claim submitters should identify the person(s) designated as the authorized official and/or technical contact(s) for any TSCA submissions asserting an expiring CBI claim.  
• Companies or company contacts with lapsed or inaccessible CDX accounts should reestablish that access by contacting the CDX helpdesk at helpdesk@epacdx.net as soon as possible.  
• Submitters should take care to preserve passphrases for TSCA submissions made in CDX to allow for future access to submissions. 

Q: Can confidentiality claims asserted in original submissions be modified or may new confidentiality claims be added? 

A: No, confidentiality claims may not be modified and new claims may not be added. Additionally, any information that was claimed as confidential in the original submission that was later denied by EPA or claims withdrawn by the submitter are no longer confidential and may not be revived through the request for extension process. When a TSCA submitter makes a request for extension of CBI claims that are due to expire, that request only applies to information that is considered valid confidential business information at the time of the request for extension. 

Q: How do I submit a copy of record request if I need to see my original submission and I have not maintained a copy and no longer have access to the submission in CDX?

A: If you are unable to access your CBI submission(s) in CDX due to a lost passphrase, you can request a copy of the submission(s) from EPA.

To obtain a copy of your submission(s), use the CDX communications tool to send a copy of record request to EPA. Read the quick reference guide for the communications tool.