EPA recently notified many companies that CBI substantiation statements are due September 19, 2017. This was a surprise to those unfamiliar with the CBI substantiation requirements imposed by the Lautenberg amendments to TSCA and EPA’s Statement of Interpretation regarding these provisions. The Statement of Interpretation was issued in the Federal Register January, 19, 2017.
The Lautenberg amendments require upfront substantiation of CBI claims. EPA data systems were not equipped to accept substantiation statements when the statute was first enacted. CBI claims made in the months between Lautenberg’s enactment and EPA updating its systems must now be substantiated. At issue are CBI claims made from June 22, 2016 to March 20, 2017.
The Agency has given companies until September 19, 2017 to substantiate claims made from June 22, 2016 to March 20, 2017. For CBI submissions made on or after March 21, 2017, all claims must be substantiated at the time the assertion is made to EPA – that is at the time the information claimed as CBI is submitted to EPA. Where there is no substantiation for a CBI claim, EPA is authorized to make the information public.
Under the amended statute, CBI substantiation must address the following:
- Identify measures the company has taken to protect the confidentiality of the information,
- Explain how disclosure of the information would harm to the company’s competitive position, and
- Determine whether or not the information must be disclosed under any other Federal law;
Some categories of information are generally not subject to substantiation requirements (§14(c)(2)) (e.g., specific information describing the processes used in manufacture or processing, marketing and sales information). Most information from health and safety studies is classified as “information not protected from disclosure” (§14(b)).
EPA provided some helpful guidance on developing CBI substantiation statements in a July 13, 2017 webinar. In addition, the has developed substantiation templates that may be used as a starting point in preparing CBI substantiations. In the templates, the EPA asks questions “to elicit facts that will help the Agency understand the basis for the submitter’s belief that a particular data element claimed as CBI is in fact entitled to this status.” Detailed responses are necessary to demonstrate the following points:
- The company’s efforts to protect the confidentiality of the information,
- How disclosure of the information would harm to the company’s competitive position, and
- That the information claimed as confidential does not appear in any public documents.
It is critical to be very detailed when developing substantiation statements. Companies get only one chance to articulate the facts that support their CBI claims. EPA procedures for reviewing CBI substantiation provide no opportunity for companies to revise or amend the statements. The only avenue for appeal, when claims are denied, is to file a petition for review in federal district court pursuant to TSCA Section 14(g)(2)(D). In such cases, the court’s review is likely to be limited to the record that was created for the Agency’s review, and additional legal or factual arguments beyond those presented to EPA are unlikely to be allowed. To ensure that substantiation statements will withstand EPA’s determination process, we encourage companies to seek legal counsel.