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U.S. Department of Health and Human Services

Science & Research

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May 30-31, 2013 Workshop: Scientific Roadmap for the Future of Animal-Free Systemic Toxicity Testing

Join us at the May 30-31, 2013 workshop A Scientific Roadmap for the Future of Animal-Free Systemic Toxicity Testing at FDA's Wiley Building in College Park, Maryland. Conveniently located near the Washington, DC-area Metro system, the workshop is free-of-charge. Pre-registration is required. Registration deadline is May 15, 2013.

The scientific roadmap was the product of an October 2011 workshop disclaimer icon held by the transatlantic think tank for toxicology (t4). Five whitepapers on systemic toxicity were prepared for workshop, taking a broad perspective on how to make further progress. The outcome was published as A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing, in the January 2012 issue of ALTEX disclaimer icon . A follow-up open meeting in Brussels in March, 2012, coorganized by numerous organizations and attended by some 150 experts, favorably reviewed and discussed the roadmap.  The FDA-sponsored May 30-31 workshop will provide a similar forum and ample opportunity for discussing the roadmap, as well as possible updates in light of recent developments.


Systemic toxicity testing includes a diverse array of assessments, like testing for carcinogenicity, reproductive effects, and skin sensitization, as well as the effects of repeated dosing and the pattern of toxicokinetics. The formidable scientific challenges of developing non-animal approaches to systemic toxicity testing assumed greater urgency given the recently enacted mandate that cosmetics marketed in Europe should be free of animal testing, including for systemic endpoints.  The time is ripe to advance a forward-looking strategy to accelerate the development of the science for systemic toxicity testing of cosmetics and others products. This focused effort applies to regions outside of Europe and to products and industries outside of cosmetics.