• One of the most common deficiencies that EPA sees is that submitters substantiate only some of the information claimed as CBI.
• Generic name deficiencies in CBI submissions include having a missing generic name and not having a structurally descriptive name.

Submitters should carefully review the entirety of their confidential business information (CBI) claim submission to avoid deficiencies. 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 but is not accompanied by an adequate generic name.

Substantiation deficiencies

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.

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).

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

Notices of deficiency

When 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).

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