• A central point for a CBI claim is consideration of whether the disclosure of the data element, whether alone, or in combination with other information, is likely to cause substantial harm to the business’ competitive position.
• EPA believes that information contained in safety data sheets, with some exceptions, generally will not qualify as CBI.
• Companies communicating with EPA by telephone or fax are advised that the lines are not secure.

There are requirements relating to the submission of confidential business information (CBI), periodic Environmental Protection Agency (EPA) reviews of CBI claims, and expiration of CBI claims. Claims of confidentiality must be made in accordance with the procedures described in 40 CFR 703. Also, see 40 CFR 720 subpart E.

All CBI claims must be substantiated at the time the information claimed as CBI is submitted to EPA, except for those types of information exempt under Toxic Substances Control Act (TSCA) section 14(c)(2). The law requires that the submitter provide a statement concerning the need for the CBI claim and a certification that the statement of need is true and correct. There is also a requirement that when a chemical identity is claimed as CBI, a non-CBI structurally descriptive generic name be provided.

EPA must, with limited exceptions, review all CBI claims for chemical identity, as well as a representative sample of at least 25 percent of other claims. These reviews must occur within 90 days of receipt. Other CBI claims can also be reviewed by the agency based on specific events.

TSCA section 5 filings are included in the universe of submissions requiring review containing CBI claims for information elements other than chemical identity. The following are some pointers that TSCA section 5 submitters should consider when making CBI claims:

• Is the TSCA CBI claim necessary? — The criteria for CBI claims are set forth in 40 CFR 2.208. A central point for a CBI claim is consideration of whether the disclosure of the data element, whether alone, or in combination with other information, is likely to cause substantial harm to the business’ competitive position.
• Is the CBI claim exempt from substantiation? — In a TSCA section 5 filing relating to a chemical substance not yet on the TSCA Inventory many data elements are exempt from substantiation. See TSCA section 14(c)(2) and 40 CFR 703.5(b)(5).
• Is the CBI claim for health and safety data or a health and safety study? — TSCA section 14(b) provides that there are limited CBI protections for these type materials. In general, study names, end points, and similar information may not be claimed as CBI. EPA believes that information contained in safety data sheets, with some exceptions, generally will not qualify as CBI. Also, EPA believes that information related to worker exposure and safety will not generally qualify as CBI. The agency has noticed circumstances where submitted studies have been claimed as CBI in their entirety. However, these “over-redactions” are not authorized under the statute.
• Has the submitter been consistent in its CBI claim for the data element? — EPA has noticed instances where a data element has inconsistently been claimed as CBI by the same submitter. The effect of this is the CBI claim will be found invalid. This is somewhat common where the company name has been claimed as CBI on a premanufacture notice (PMN) form, but the name is not claimed as CBI in an attachment.
• If the specific chemical name is claimed as CBI, is a structurally descriptive generic name provided? — EPA has observed instances of generic names being provided which do not meet this standard. EPA has also observed instances where the provided generic name is exactly the same as the actual name.

E-PMN and CDX allow safe CBI reporting

The e-PMN Software and EPA’s databases are designed for anyone to safely transmit TSCA CBI via EPA’s electronic Chemical Data Exchange (CDX). As a person completes the form and provides attachments, the tool automatically zips everything into one file. The tool then automatically encrypts this file and (after verifying the UserID, Password and the 20-5-1Questionnaire) sends it through CDX to EPA. CDX is unable to open up the submission.

EPA receives a matching decryption key with the submission in a secure environment. Only EPA has the matching decryption key; therefore, the TSCA CBI is fully protected. EPA then decrypts and unzips the submission for further processing. A person should not email any CBI to EPA. The agency’s email system is not secured to protect CBI.

Faxes and telephone calls

Companies communicating with EPA by telephone or fax are advised that the lines are not secure. When someone has a telephone conversation with EPA involving CBI, the person should confirm with the EPA representative (program manager, chemist, pre-notice coordinator, etc.) about authorization to discuss CBI.

If an individual is faxing CBI material to EPA, the person must contact a new chemicals program staff person prior to faxing to ascertain that they are in the office that day and ready to receive the fax AND the fax must be appropriately identified by the submitter as CBI. The fax should include a cover sheet with the name of the EPA recipient and the total number of pages. The New Chemicals Management Branch fax number is (202) 564-9490.