REGULATORY ALERT: TSCA REFORM AND THE IMPACT ON CONFIDENTIAL BUSINESS INFORMATION (CBI)

28 July, 2016

What’s Happening?

With the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (TSCA 21), there are many changes to the Toxic Substances Control Act.  One important change is how the EPA will be handling confidential business information (CBI) going forward.  Under TSCA 21, the EPA will be reviewing all CBI claims.

How Could it Impact Me?

There are currently 17,000 chemicals on the confidential portion of the TSCA Inventory.  Until now, there has been no mandate to review these claims.

EPA must determine which chemical substances on the current TSCA Inventory are active in commerce.  In order to comply with a final rule expected to be published in 2017, industry will need to notify EPA of all chemical substances manufactured or processed during the 10 year period prior to the enactment of TSCA 21 in May, 2016.  Once these active chemicals have been identified, EPA must promulgate a rule to review all claims to protect the identities on the confidential inventory.

In addition, within 5 years of the final rule being passed, the EPA must review all existing CBI claims.  All new CBI claims must be reviewed and approved by the EPA.  Approved claims will expire after 10 years unless they are re-substantiated.

The EPA may now share confidential information with state organizations, first responders and health and environmental organizations to protect the health and the environment as long as non-disclosure agreements are signed.  This is a big change from the previous version of TSCA where the EPA was not authorized to share CBI information with any parties.

The previous version of TSCA did not allow health and safety data to be claimed as confidential and the identities of chemical substances in these studies were not permitted to be masked.  This requirement has not changed with the implementation of TSCA 21.

Contact Us:

Critical Path Services can help you to understand how TSCA 21 will change the handling of Confidential Business Information in the future and how you can position your company now to be ready for this change.

Critical Path Services can also provide a free consultation with your company to talk you through the major changes in the new law and how these changes 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