Deficient TSCA CBI Submissions

• Deficient CBI claims
• Making sure all CBI claims are substantiated
• Responding to a notice of deficiency
• Obtaining a copy of your CBI submission
• EPA Contacts

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Deficient CBI Claims

A CBI claim is deficient if it meets one or more of the following criteria:

• The claim is not accompanied by a required supporting statement and certification. 
• The claim is not accompanied by required substantiation OR asserts an inapplicable substantiation exemption.
• The claim is not accompanied by an appropriate public copy or “sanitized” version.
• The claim is for a specific chemical identity does not include or does not include an adequate generic name.

When these deficiencies are identified, EPA will provide electronic notice and a 10 business day period to correct the deficiency. If the deficiency is not remedied during the 10 day period, EPA will proceed with review of the submission and may deny the CBI claim(s). See also 40 CFR 703.5(e).

Making Sure All CBI Claims Are Substantiated

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 where needed; and
• if a CBI claim is for specific chemical identity, a structurally descriptive generic name.

One of the most common deficiencies that EPA sees is that submitters substantiate only some of the information claimed as CBI. In particular, submitters will often only substantiate claims for specific chemical identity but not for other information that is claimed as CBI. Submitters should carefully review the entirety of their submission, including all studies, correspondence, and other attachments for information that is being claimed as CBI and make sure there is a substantiation for every information element in all the documents. Learn more about how to substantiate CBI claims. 

If a submitter wishes to assert that certain information is exempt from substantiation (in addition to information already identified in the reporting application as exempt), it must be noted in the substantiation section of the submission, citing the exemption and the reason it applies to the specific claimed information. In most reporting applications, the submitter may select the “opt out” box for substantiating the claim and then provide an explanation in the pop-up box. See also 40 CFR 703.5(b)(5). Learn more about what information EPA considers to be exempt from substantiation under TSCA.

EPA electronic reporting systems within the Central Data Exchange (CDX) prompt users for required generic name and substantiation when CBI claims are made.

Responding to a Notice of Deficiency

Deficiencies may generally be corrected by logging into the submission via CDX, amending it to correct the deficiency (or withdraw the claim), and then resubmitting.

Obtaining a Copy of Your CBI Submission

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.

EPA Contact

For more information on notices of deficiency please contact:

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