Discontinuation of Notices of Deficiency for Confidential Business Information (CBI) Claims Under the Toxic Substances Control Act (TSCA)

TSCA
22 July, 2019

What’s Happening?

When businesses submit non-exempt CBI claims without the required substantiation USEPA sends a notice of deficiency providing an opportunity to correct the error.  Beginning on August 15, 2019* USEPA will no longer send out notices of deficiency when:

  • submissions containing non-exempt information claimed as CBI do not include substantiation for all such claims;
  • the CBI claims have other procedural flaws such as a missing certification statement;
  • CBI claims for specific chemical identity do not include a generic name.

Instead, the Agency will provide written notice to affected submitters that the CBI claims are invalid and the underlying information is subject to disclosure without further notice.

* See Federal Register 84 FR 33939, July 16, 2019

How Could it Impact Me?

Notices of the deficiency afforded the affected business 30 days to submit the required information.  Since March 21, 2017 USEPA sent 984 notices of deficiency, the vast majority related to submissions received before that date.  Only 97 notices have been generated related to filings between March 21, 2017 and July 16, 2019.  Now the only notice that will be sent will inform the recipient that the claim is invalid and that the information may be made public immediately.

Bottom Line

If you submit a notice to USEPA that includes non-exempt information that is claimed to be confidential it is imperative to assure that all required substantiation information and certifications are provided to the Agency.  For further information see https://www.epa.gov/tsca-cbi.

Our support

knoell USA, LLC will continue to follow TSCA developments and can provide your company with periodic TSCA updates to assist you in addressing future regulatory requirements.  knoell USA can also provide representatives of your company with a free consultation to talk through the ongoing issues and how they could affect your business.

 

Business Units: 
Elizabeth Dederick, Ph.D. Vice President, Industrial Chemicals and Biocides
+1 610 558 3001 Ext. 102 +1 610 558 6025 send mail