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Protecting Your Confidential Business Information after TSCA Reform

September 2016

A key aspect of the Lautenberg Act’s reforms is the way it changes the treatment of Confidential Business Information (CBI) claims. These changes will impact both companies who submit new claims for CBI protection and those who have previously claimed CBI protection. To ensure CBI remains protected, companies will need to take greater efforts than were previously needed.

Most importantly, the Lautenberg Act changes the requirements for new claims for CBI protection. Historically, submitters needed only to make a CBI claim. After the new Act, a company must now affirmatively substantiate all new claims for CBI protection at the time the claims were made, except under limited circumstances where confidentiality is presumed without substantiation.1 This is a wholesale change of EPA’s practice regarding CBI claims, and will require significant adjustments from both industry and EPA.

The Lautenberg Act does not specify what materials EPA will require for substantiation, but requires EPA to establish substantiation requirements by rule. Those wishing to limit the burden of substantiating CBI claims should watch for this rulemaking and actively participate. In addition, companies should plan to gather additional information supporting CBI claims as they prepare to submit information as part of the chemical review process.

Even before EPA promulgates its CBI rule, the Lautenberg Act mandates numerous changes to EPA’s procedures. For example, EPA must now review and approve or deny all CBI claims for specific chemical identity. When claiming a specific chemical identity is CBI, a company must provide a structurally descriptive generic name for EPA to use. EPA will also review CBI claims relating to information other than the chemical identity. Thus, not only should companies prepare to meet the substantiation requirements, but they should also prepare for possible questions from EPA during the agency’s reviews.

The Lautenberg Act also requires EPA to review past claims for CBI protection. EPA can require resubstantiation for any active or high-priority substances, or whenever EPA determines disclosure would assist EPA in risk evaluations and rulemaking. EPA must require resubstantiation for past claims when there is reason to believe the information does not qualify for protection or when EPA determines a substance presents an unreasonable risk. In addition, within one year of creating the active substance list under Section 8, EPA must promulgate a rule to plan its review of CBI claims for the chemical identity of active chemicals. Therefore, companies that are not actively bringing new chemicals to market may be surprised when EPA asks them to substantiate prior CBI claims, particularly claims that a chemical identity should not be disclosed. Companies with existing CBI claims may want to prepare the necessary documentation as soon as feasible.

If the EPA grants protection for CBI, the protection only lasts for ten years unless a request for extension is filed. A company must re-claim protection at least thirty days before the 10 year period expires. Failure to submit a request for continued protection could leave companies at risk of having the CBI disclosed. In addition, when chemicals are banned or phased out, EPA may also disclose the CBI unless a company asks within 30 days of the phase-out or ban for that information to remain confidential. Companies who have made prior claims for CBI protection should carefully monitor these deadlines to avoid accidental disclosure.

On the whole, under the Lautenberg Act, EPA will scrutinize claims for CBI protection more thoroughly and will require more substantiation than previously. Companies must prepare for these additional requirements to ensure important information is not disclosed.

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1  These are: (A) Specific information describing the processes used in manufacture or processing; (B) Marketing and sales information; (C) Information identifying a supplier or customer; (D) In the case of a mixture, details of the full composition of the mixture and percentages of constituents; (E) Specific information regarding the chemical use or application in a process, mixture, or article; (F) Specific production or import volumes; (G) Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of the chemical substance, if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under section 5.