“Toxicity Testing in the 21st Century” and reforming the science of toxic chemicals regulation

In light of recent developments in biotechnology and computational toxicology, there is an unprecedented opportunity to improve risk-based regulatory decision-making by modernizing outmoded US toxic chemical laws that continue to rely on time-consuming, resource-intensive animal-based studies that are of questionable relevance to humans. At the behest of the Environmental Protection Agency (EPA), The National Research Council (NRC) devised a new approach to toxicity testing that recognizes the impact of these scientific developments. The result of this effort, NRC's 2007 publication, “Toxicity Testing in the 21st Century: A Vision and A Strategy,” outlines a transformative paradigm shift in toxicology from an observational to a predictive science. Based largely on non-animal test methods, this shift favors high-throughput assays capable of managing large numbers of chemicals and mixtures at relatively low cost. NRC notes that the observational approach to toxicology does not ensure the most appropriate public health decision-making; it is therefore essential that any new legislation governing the regulation of chemicals not only incorporate available predictive methodology, but also stimulate development of novel toxicity assessment approaches consistent with the NRC strategy. Applying the NRC recommendations, we suggest an intelligent EPA Endocrine Disruptor Screening Program (EDSP) testing strategy that would result in more efficient screening and characterization of the endocrine-disrupting potential of manufactured chemicals while reducing reliance on the use of animals. As regulatory toxicology impacts all populations, some more vulnerable than others, robust risk assessment is a centrally important tool for making public health decisions regarding chemical production and use.