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; at ILSI in Washington, DC; and at the University of North Carolina – Chapel Hill. 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.

Registration for this workshop is through the 2008 Toxicology and Risk Assessment Conference website.  Click here to go to the conference website. 

For more information, see:

• Workshop Description
• Workshop Agenda
• Workshop Speaker/Facilitator Bios 
• Selected Reference Materials