Changes to the U.S. Toxic Substances Control Act:
new risk assessment paradigm and its practical implications
The United States Congress radically changed some aspects of the 1976 Toxic Substances Control Act (TSCA) in June 2016 with the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (CSA) of 2016. Other aspects of TSCA crucial to bringing a chemical product to market remain unchanged. This article summarizes developments under the CSA and provides practical insights for companies seeking to manage business risks resulting from the evolving regulatory landscape.
The Toxic Substances Control Act (TSCA) passed in 1976 was revolutionary in its time. It gave the United States Environmental Protection Agency (US EPA or Agency) unprecedented authority to regulate industrial chemicals that were already on the market and included provisions for the pre-manufacture notification and evaluation of new chemical substances (1). But as experience with TSCA grew many observers identified flaws. It restricted USEPA’s ability to collect data on new chemicals and regulated chemicals based on “unreasonable risk” without explicitly defining the term, among other shortcomings (2).
TSCA reform finally became reality on 22 June 2016 with the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (CSA) of 2016. The CSA changed some crucial aspects of TSCA, notably related to the requirements to assess the risks from exposure to chemicals. This paper begins with a comparison of the risk assessment paradigms under the old and new laws, and then explores the implications of this change for existing and new chemicals. It concludes with pragmatic advice for companies manufacturing chem ...