Author
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Norred, William |
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Submitted to: US-Japan Coop Pgm on Dev and Util of Natural Products Abstracts Proceedings
Publication Type: Abstract Only Publication Acceptance Date: 2/1/2002 Publication Date: N/A Citation: N/A Interpretive Summary: Abstract only. Technical Abstract: The objective of the risk assessment process is to provide the basis for decisions that will allow successful management of the risk. Poor risk management decisions that result from inadequate risk assessment can be enormousely costly, both economically and in terms of human or animal health. Acccording to the National Academy of Sciences, assessment is defined by hazard identification, dose-response assessment, exposure assessment, and risk characterization. The quality of the overall risk analysis is dependent on the accuracy and completeness of these four individual components. In the case of mycotoxins, risk analysis is compromised because of the unpredictability of contamination, the variability in exposure, and the relative paucity of dose-response and risk characterization data. In the United States, the philosophy of regulatory agencies is that standards should be based on the best and most current science, including utilization of available information on mechanism of action of the contaminant. The United States is committed to international standards for consumer protection, but only if there is an international trade problem. The overriding concern is that contamination be minimized, i.e, that prevention is the best control. Complete prevention may not be entirely possible for many contaminants, including mycotoxins, and therefore allowable limits may need to be set. In an attempt to deal with the uncertainities that exist, the Food and Drug Administration uses a risk assessment method referred to as "safety assessment". This practice introduces uncertainty factors in which the no observable adverse effect level obtained from animal studies is reduced by a factor of 10 for each unknown variable, such as interspecies differences. Thus an "action level" often reflects 100-fold or 1000-fold safety margins, depending on the number of unknown sources of variation. These factors are routinely used both in the United States and internationally in order to provide the greatest possible degree of protection to the consumers of agricultural commodities. |
