An ILSI Research Foundation Workshop
University of North Carolina Friday Center, Chapel Hill, NC
Februrary 12, 2008
The Scene: A risk assessment group in a government agency is reviewing the data on Chemical X, as they develop recommendations for a health-based standard. The carcinogenicity study in rats showed a few animals with urinary bladder tumors, an unexpected finding. Someone asks if it’s possible that the tumors are related to the crystals found in the bladders of some of the animals and whether people could be exposed to a high enough level of Chemical X to produce crystals. Do we know the mode of action for crystal formation? For bladder tumor induction? How do we systematically work through the evidence to evaluate the relevance of these tumors for our risk assessment?
Another Scene: A product development group at a chemical company is preparing to submit data on a new product for government approval. Someone notices a toxicology study in the information package that reports some cytotoxic changes in mouse liver, but the changes are not mentioned in the toxicology summary in the package. The lab is consulted, and the toxicologist says that the changes were minor and only at the high dose, so they weren’t considered to be relevant. But will that ‘fly’ with the government reviewers? Is there an accepted systematic approach for evaluating the relevance for humans of a postulated mode of action in animals?
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The ILSI Research Foundation, in collaboration with scientists from the U.S. Environmental Protection Agency and Health Canada, will present a workshop on the application of a framework for evaluating the human relevance of modes of action in animals. The framework, developed over the past several years, has already been widely adopted and used by government agencies and international organizations.
This full-day workshop is an expansion of the highly successful workshop presented at Society for Risk Analysis Meetings in Baltimore and San Antonio and at ILSI in Washington, DC. Combining tutorial presentations with interactive case studies, the workshop will be particularly helpful for scientists from government, industry, academia, consulting firms, or other organizations involved in conducting, reviewing, and interpreting toxicology studies and risk assessments.
This workshop also will feature opening remarks by Dr. George Gray, EPA Assistant Administrator for Research and Development, speaking on “Advancing Risk Assessment at EPA.” This presentation and the opening workshop tutorials are open to the public at no charge; the remainder of the workshop, including the interactive case studies, is limited to workshop registrants. The workshop will conclude with a Plenary Lecture given by Dr. James Swenberg, UNC Chapel Hill titled “Key Events for a Mutagenic MOA: Implications for Risk Assessment”.
For more information, see:
Contact:
Dr. Steve Olin, Workshop Organizer (solin@ilsi.org)
Ms. Julie Fitzpatrick, Worshop Co-Organizer (jfitzpatrick@ilsi.org)
Ms. Audrey Ray, Registrar (aray@ilsi.org)