Using Human Data in Risk Assessment to Protect Public Health. M. E. Andersen, Colorado State University; M. L. Dourson, TERA; L. S. Erdreich, Exponent; J. A. MacGregor, Toxicology Consulting Services; and C. J. Portier, NIEHS
We investigate the use of human data in the risk assessment and risk management processes as defined by the National Academy of Sciences (NAS, 1983). Although the use of such data has a long and successful history in the risk assessment for environmental contaminants and in the development of drugs and commercial chemicals, recent deliberations within the U.S. Environmental Protection Agency (and perhaps elsewhere), have questioned this practice. The purpose of this research is to compare the use of ethically-derived and scientifically-credible data from either experimental animals or humans when deriving "" human doses for environmentally-relevant chemicals. We test the hypothesis that the direct use and interpretation of human data, in conjunction with data gathered from experimental animals, is a public health protective policy that should be encouraged. Research areas include the comparison of human- and experimental animal-based risk specific doses (RSDs), reference doses (RfDs), and Reference Concentrations (RfCs), and the comparison of human and experimental animal data on toxicokinetics and toxicodynamics. Within the framework of risk assessment, discussion topics will include whether human data are to be preferred over data from experimental animals, when is the use of human data unethical, and what is the public health value of the estimating the most scientifically credible risk number?
This research is supported through the use of developmental reserve funds of TERA.
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