Uncertainties in the risk assessment of three mycotoxins: aflatoxin, ochratoxin, and zearalenone.

The risk assessment of mycotoxins is made up of two major components: an exposure assessment and a hazard assessment. There are many uncertainties in both of these components. This paper will briefly discuss the various aspects of the risk assessment process as it applies to mycotoxins and will then focus mainly on some of the uncertainties in the hazard assessment component of several carcinogenic mycotoxins. To arrive at an estimated "safe dose" (end point of the hazard assessment), we have previously used two major approaches: the no observed effect level (NOEL) divided by a safety factor approach and a mathematical (robust linear) extrapolation to a "virtual safe dose." Both of these approaches use only points from the no observed effect region of the dose-response curve and ignore valuable data from the response region. It is proposed to use the dose at which 50% of the animals would have developed tumors (the TD50) divided by a large safety factor of 50,000 as an additional estimate of "safe dose". For many studies, the TD50 lies within the observed response region of the dose-response curve and may have more validity. It is also suggested in certain cases that some of the uncertainties regarding the NOEL can be reduced if one uses a statistically derived no effect level (NEL).