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Toxicological Sciences 2005 86(1):1-3; doi:10.1093/toxsci/kfi133
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Published by Oxford University Press 2005.

EDITORIAL

A Risk Assessment Perspective: Application of Mode of Action and Human Relevance Frameworks to the Analysis of Rodent Tumor Data

Vicki L. Dellarco1 and Karl Baetcke

U.S. Environmental Protection Agency, Office of Pesticide Programs, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460

1 To whom correspondence should be addressed. Fax: +1-703-5147; E-mail: dellarco.vicki@epamail.epa.gov.

Received February 18, 2004; accepted February 23, 2005

Key Words: cancer risk assessment; carcinogenicity mechanisms; human relevance; dose–response assessment.

The first 10% of the full text of this article appears below.

When the United States Environmental Protection Agency (USEPA) published guidelines for carcinogen risk assessment in 1986, it provided essentially no guidance on how to consider mechanistic information. The guidelines simply pointed out that "The Agency will review each assessment as to the evidence on carcinogenesis mechanisms and other biological or statistical evidence that indicates the suitability of a particular extrapolation model." (USEPA, 1986Go). At that time, mechanisms of carcinogenesis were largely unknown and empirically difficult to approach. Nonetheless, as mechanistic data became available, the Agency considered it in formulating science policies, e.g., alpha2u-globulin–induced rat renal tumors (USEPA, 1991Go) and thyroid follicular cell rodent tumors and disruption of thyroid homeostasis (USEPA, 1998Go) or in chemical-specific assessments, e.g., bladder tumors induced by melamine through formation of urinary calculi (USEPA, 1988Go).

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