A key goal of the Lautenberg Chemical Safety Act (LCSA) is to increase available information concerning the health effects of both new and existing chemicals.  One common complaint about the original Toxic Substances Control Act (TSCA) was that it did not require the acquisition of comprehensive data on the health effects of chemical substances, leaving gaps in our understanding of potential health risks.  LCSA joins an array of newer, national or supranational regulatory schemes including REACh in the European Union and similar regulations in other countries (China, Korea, Malasia) that require substantial data on chemical health hazard prior to chemical registration and sale.  Various green chemistry initiatives also create a need to fully understand the potential health effects of chemicals, particularly to fully vet potential new chemical alternatives and avoid regrettable substitutions.  Combined, these new programs add substantially to the overall demand for chemical health hazard testing and data gap filling.  However, existing chemical testing approaches (e.g., traditional animal study toxicology) are limited in terms of the information they provide and are too slow and too expensive to meet the expanding need.  Ten years ago, the U.S. National Research Council published Toxicity Testing in the 21st Century: A vision and a strategy.  In the intervening 10 years, we have seen tremendous advances in both the basic research needed to support data gap filling strategies and in the availability of tools to implement the results of that research.  Cell-based, cell-free, inferential and computational methods for predicting chemical toxicity are increasingly being used in chemical development and are slowly but surely gaining regulatory acceptance.  This session highlights some of the latest approaches and tools available for chemical hazard evaluation.  This initial talk will briefly establish the regulatory context for the presentations that follow.

Chemical safety evaluation challenges of the Lautenberg Chemical Safety Act

255th National Meeting (2018)

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