Revised Toxic Substances Control Act - Challenges for “new” and “existing” substances

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The Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) changes many components of the original US Toxic Substances Control Act (TSCA) statute. These include the addition of systematic evaluation of existing chemicals, introduction of new concepts to the assessment of new chemicals, and altering how confidential business information (CBI) is reviewed and maintained. The effects of the existing chemicals prioritization and risk evaluation process on industry have yet to be realized. Changes to the new chemical process continue to evolve. However, it is clear that the use of “insufficient information” findings and the inclusion of “reasonably foreseeable uses” in the new chemical review process have had a profound effect on the outcomes of assessments, resulting in a reduction in the number of new chemicals that are commercialized. Changes to the procedure for protection of CBI protection make requirements for substantiation more frequent and more challenging.

Learning Objectives:

1. Understand the paradigm shift that occurred in chemicals regulation in the US when TSCA was amended.

2. Understand the impact of the addition of systematic evaluation of existing chemicals on TSCA chemicals management.

3. Understand how concepts such as the use of "insufficient information" findings and the inclusion of "reasonably foreseeable uses" have impacted new chemicals risk assessment under TSCA.

4. Understand changes to the procedure for protection of confidential business information (CBI).

Presenter: Jeffrey Hafer, Knoell USA, Senior Scientist

During a 36-year career in industry Jeff Hafer held a variety of positions at Rohm and Haas and Dow Chemical including global regulatory specialist and global product stewardship manager for the Coatings business. In 2013 he became corporate TSCA manager for Dow Chemical. After retiring from Dow in 2016, Jeff joined knoell USA as a Senior Regulatory Scientist. During his career Jeff served as chair of the American Chemistry Council’s Regulatory Advocacy and Information Network, the American Coatings Association’s Product Stewardship Committee, and the Emulsion Polymers Council.

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