Abstract
The traditional approaches to toxicity testing have posed multiple challenges for evaluating the safety of commercial chemicals, pesticides, food additives/contaminants, and medical products.The challenges include number of chemicals that need to be tested, time and resource intensive nature of traditional toxicity tests, and unexpected adverse effects that occur in pharmaceutical clinical trials despite the extensive toxicological testing.Over a decade ago, the U.S. Environmental Protection Agency (EPA), National Toxicology Program (NTP), National Center for Advancing Translational Sciences (NCATS), and the Food and Drug Administration (FDA) formed a federal consortium for "Toxicology in the 21st Century" (Tox21) with a focus on developing and evaluating in vitro high-throughput screening (HTS) methods for hazard identification and providing mechanistic insights.The Tox21 consortium generated data on thousands of pharmaceuticals and datapoor chemicals, developed better understanding of the limits and applications of in vitro methods, and enabled incorporation of HTS data into regulatory decisions. To more broadly address the challenges in toxicology, Tox21 has developed a new strategic and operational plan that expands the focus of its research activities. The new focus areas include developing an expanded portfolio of alternative test systems, addressing technical limitations of in vitrotest systems, curating legacy in vivo toxicity testing data, establishing scientific confidence in the in vitrotest systems, and refining alternative methods for characterizing pharmacokinetics and in vitro assay disposition.The new Tox21 strategic and operational plan addresses key challenges to advance toxicology testing and will benefit both the organizations involved and the toxicology community.
Highlights
The traditional approaches to toxicity testing have posed multiple challenges for evaluating the safety of industrial and environmental chemicals, pesticides, food additives, food contaminants, and medical products
Apart from specific classes such as pesticides and medical products, most chemicals have undergone limited, if any, traditional toxicity testing leading to a lack of adequate information to Disclaimer: This article does not necessarily reflect the policy of the US Environmental Protection Agency, National Toxicology Program, National Institutes of Health, or Food and Drug Administration
Based on the recommendations in this report, a joint effort was initiated through a Memorandum Of Understanding (MOU) executed by the U.S Environmental Protection Agency (EPA)/Office of Research and Development/National Center for Computational Toxicology (NCCT), National Institutes of Health (NIH)/National Institute of Environmental Health Sciences/National Toxicology Program (NTP), and the NIH/National Chemical Genomics Center (NCGC), previously a part of the National Human Genome Research Institute and a part of the National Center for Advancing Translational Sciences (NCATS) (Collins et al, 2008; Kavlock et al, 2009)
Summary
The traditional approaches to toxicity testing have posed multiple challenges for evaluating the safety of industrial and environmental chemicals, pesticides, food additives, food contaminants, and medical products. Based on the recommendations in this report, a joint effort was initiated through a Memorandum Of Understanding (MOU) executed by the U.S Environmental Protection Agency (EPA)/Office of Research and Development/National Center for Computational Toxicology (NCCT), National Institutes of Health (NIH)/National Institute of Environmental Health Sciences/National Toxicology Program (NTP), and the NIH/National Chemical Genomics Center (NCGC), previously a part of the National Human Genome Research Institute and a part of the National Center for Advancing Translational Sciences (NCATS) (Collins et al, 2008; Kavlock et al, 2009) This collaboration, informally called Tox, was formed to address the goals of: (1) identifying mechanisms of chemically induced biological activity; (2) prioritizing chemicals for more extensive toxicological evaluation; and (3) developing more predictive models of in vivo biological response. A collaboration of this type and duration is unique within the federal government
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