Several federal agencies including the National Institute of Environmental Health Sciences (NIEHS), the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) have initiated a Toxicology for the 21st Century (Tox21) program, designed to evaluate the utility of a broad range of in vitro tests for predicting the toxicity of chemicals. Its ambitious intent is to transform toxicology testing over the next decade.
The in vitro tests used in the Tox21 program are based on procedures developed by the pharmaceutical industry for drug development called high throughput screening (HTS). Although the application of HTS offers many potential benefits (e.g., less time required to conduct testing, decreased cost, increased reliability, less animal testing), the methods are not validated for use in predicting toxicity. This means that the occurrence of false positive and false negative results from these tests is not known at this time. Given this lack of knowledge, there is risk that safe chemicals, many of which are used as food and consumer product ingredients, will be falsely characterized as unsafe.
GMA continues to monitor the progress made in the Tox21 program and is a partner with several organizations that are actively engaged with testing validation and data interpretation activities. Our members are committed to consumer safety and take our responsibility to produce safe products seriously. This application of data from validated Tox21 in vitro testing will provide an efficient and rapid process to evaluate chemicals used in consumer products and packaged goods.
GMA Tox21 newsletters:
Provides GMA members with important news and updates regarding the federal Tox21 initiative and critical information on the impacts on this program to the food and consumer product industry.
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GMA Contact: Manojit Basu, Ph.D. - Technical Lead, Consumer Product Safety & Regulatory Affairs