TSCA’ s next CBI crisis is already underway
Companies must act now to preserve their expiring confidential business information claims, says Philip A. Moffat of Verdant Law
For nearly 40 years, companies asserting confidential business information( CBI) claims under the Toxic Substances Control Act( TSCA) could rest easy, knowing that the US Environmental Protection Agency( EPA) was unlikely to publicly disclose the information. That all changed in 2016. Since then, there have been several events when CBI protections have been at risk and another is fast approaching.
TSCA is the primary means of regulating industrial chemicals in commerce in the US. In 2016, Congress amended the statute, instituting among other changes a ten-year expiration date for most CBI claims. This marked a significant shift: previously, companies could assert a claim, provide justification, known as‘ substantiation’, or sometimes none at all, and move on.
Now, ten years later, the first CBI claims made under amended TSCA are beginning to expire, starting in June. Companies can extend CBI protection by submitting a substantiated‘ request for extension’ at least 30 days prior to a claim’ s expiration. If approved, protection extends for another ten years.
The stakes are high. If a company misses the 30-day deadline by even a single day, TSCA could be interpreted as authorising the EPA to disclose the CBI without further notice or opportunity for judicial review.
What’ s at risk?
CBI claims are commonplace. It is unusual for a company to make a TSCA submission without seeking confidential treatment of at least one piece of information, such as production volumes or the company’ s name. Most importantly, companies often claim the specific chemical identities of their proprietary chemicals as CBI.
If your company has ever made a CBI claim, a strong likelihood for any company manufacturing, importing or processing industrial chemicals in the US, you should begin preparing now for CBI expiration and renewal. This applies even to companies that do not believe that any of their claims will expire imminently, because claims can expire ahead of schedule in certain circumstances, as explained below.
For many companies, preparation will involve ensuring access to‘ CDX,’ the EPA’ s electronic filing system and the location of almost all post-2016 TSCA submissions. It will also mean developing a catalogue of claims with their expected expiration dates and monitoring EPA notifications of expiring claims.
Lessons from Reset
Unfortunately, companies cannot afford to rely on the EPA to act predictably or fairly during the CBI expiration and renewal process. The EPA’ s last significant foray into TSCA CBI caused many companies to lose CBI protection for otherwise deserving information, simply because they took the EPA at its word.
This episode, known as‘ Inventory Reset,’ was another element of the 2016 amendments to TSCA. The TSCA‘ Inventory’ is a list of all non-exempt industrial chemicals in commerce since TSCA’ s passage, maintained by the EPA. The 2016 amendments required the EPA to determine which of these chemicals were actively in commerce and the agency promulgated a rule requesting that information from manufacturers and importers.
50 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981