Compliance: Successfully Substantiate CBI Claims

Any confidential business information claims that aren’t validated may be made public

By Lynn L. Bergeson

On September 15, 2017, the Environmental Protection Agency (EPA) announced that due to the impact of Hurricanes Harvey and Irma, the agency is extending the deadline to submit and claim information as confidential business information (CBI). Manufacturers now have until October 19, 2017 to submit the substantiations required by Toxic Substances Control Act (TSCA) Section 14(c)(3).

We offer several useful suggestions in preparing substantiations.

Background

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued an interpretation of the TSCA Section 14 concerning substantiation of CBI claims for information submitted to the EPA. The agency expressed its view that new TSCA requires substantiating all non-exempt CBI claims at the time such information is submitted. The EPA noted that the action will “facilitate [its] implementation of TSCA section 14(g) to review all CBI claims for chemical identity, with limited exceptions, as well as to review a representative sample of at least 25% of other non-exempt claims.” CBI claims made as part of an existing submission in the EPA’s Central Data Exchange (CDX), such as information claimed confidential in a premanufacture notice (PMN), must be validated by amending the CDX submission. Other information should be submitted using the same mechanism (e.g., substantiate claims made in paper submissions by submitting substantiations on paper). The action was effective as of March 21, 2017, after which any non-exempt CBI claim must be proven at the time of submission. The EPA will consider CBI claims that aren’t authenticated to be deficient, resulting in a notice sent to the affected business that it must remedy the substantiation deficiency within 30 calendar days or the information may be made public.

Implementation

The EPA urges businesses to look at the substantiation questions found at 40 C.F.R. Part 2, Section 2.204(e) for guidance on how to meet the Section 14(c)(3) requirements for information not currently subject to regulatory substantiation. The EPA states that the answers to those questions typically form the basis to determine final confidentiality, and that substantiations that don’t address those questions “might not provide sufficient information to uphold” a TSCA Section 14(g)(1) determination that the information is eligible for CBI protection.

Helpful Tips

We offer several useful suggestions in preparing substantiations.

Review EPA templates. The EPA provides templates for substantiating CBI claims. These templates are suggested, but not required. If you elect to use a different document to validate CBI claims, be sure to address all the elements in the template files. A substantiation document may itself contain CBI. Be sure to indicate what content in the document is CBI and that such claims are also substantiated, or note any substantiation exemptions that apply. Include a sanitized copy of the document when the substantiation document is submitted to EPA; CDX will require a sanitized copy of any document that includes a CBI claim.

Review prior submissions. If you have not timely done so, review all documents submitted between June 22, 2016, and March 21, 2017, for information claimed as CBI. In each submission, review each data element claimed as CBI in a Section 5 notice, chemical data reporting (CDR) submission or other type of document, and consider carefully whether the information is truly confidential. The EPA reportedly has found that a surprising number of claims thought to be CBI actually have been made public by the submitter on a website or is otherwise publicly available.

Review claims to assess if any are exempt from substantiation. Review the remaining data elements claimed as CBI to assess if any are exempt from substantiation under Section 14(c) and note which subparagraph applies to each such claim. Be sure to identify which data elements are exempt and the applicable exemption listed in TSCA Section 14(c). For data elements not exempt from substantiation, review each and answer the substantiation questions included on the templates, the first of which is to describe the substantial harm to the company’s competitive position that would result from the disclosure of that information.

Above all, follow the rules and comply with them consistently. Exercise care in managing CBI claims, assert them prudently, and only when warranted.


bergeson-color.jpgLYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at lbergeson@putman.net

Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.

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