AltTox Digest
August/September 2010

Andersen and Krewski Respond to Toxicol. Sci. Commentaries

A year ago, an article by Mel Andersen and Dan Krewski and an accompanying editorial kicked off a year-long Forum Series in the journal Toxicological Sciences devoted to the National Research Council's 2007 report on Toxicity Testing in the 21^st Century: A Vision and a Strategy. Since then, eight commentaries were published by scientists in industry, government, and academia. The commentaries ranged from cautious to optimistic about the NRC vision of basing chemical risk assessments on the toxicity pathways approach. In the final installment in the series, Andersen and Krewski—key members of the committee that developed the NRC report—respond to the commentaries and offer thoughts on "Moving from Discussion to Action" (the subtitle of their article).

Their response makes several inter-related points, among which are the following. First, the intent of the NRC vision was not to replace animal use but to apply modern tools to present-day challenges. Second, the NRC report went beyond a general endorsement of high through-put technologies per se and instead called for their application to risk assessment. Third, the proposed tools are not intended as better predictors of animal-based results (hazard identification) but as a new human-focused safety paradigm, aiming to avoid human exposures at levels that would trigger harmful toxicity pathway perturbations. Fourth, validation of the new paradigm should be based primarily on a detailed understanding of toxicity pathways, not a comparison to existing animal data.

Andersen and Krewski approvingly quote a lengthy passage from Chapin and Stedman's commentary that echoes the approach in the NRC report, but a critical distinction is left unaddressed. Chapin and Stedman speculate that it may be sufficient to observe which tissues show threshold changes associated with toxicity and not necessarily follow all the downstream effects through to frank toxicity. The upstream, threshold effects would flag a compound as potentially toxic and "lead to its testing in animals." This outlines a sophisticated screening approach that prioritizes chemicals for follow-up testing in animals; in its fullest form the NRC vision supplants the need for such animal testing.

Andersen and Krewski end with a unifying plea. All eight commentaries agree that the challenges to implementing the NRC vision are such that the path forward will not be easy. Andersen and Krewski call for collaboration across scientific disciplines to bring the vision to life. Clearly this scientific collaboration will be the core activity but we would also emphasize the need for supportive public policy action (e.g., facilitative legislation, regulatory activity, and funding) and concerted action across sectors (government, industry, academia, public interest) and countries.

Reference: Andersen, M.E. & Krewski, D. (2010). The Vision of Toxicity Testing in the 21^st Century: Moving from Discussion to Action. Toxicol. Sci. 117 (1), 17-24.

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