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human health effects of this naturally occurring toxin and its suspected occurrence in portions 

 of the 1993 wheat crop. It was not until FDA issued its new advisory levels on September 

 16, 1993 that our industry was certain as to whether the 1982 advisory levels would become 

 more or less stringent, or whether the advisory levels would become action levels. 



The distinction between action levels and advisory levels is important to our industry. 

 Advisory leveb are relied upon as indicators from FDA as to specific levels of vomitoxin 

 that the agency believes provides a more-than-adequate margin of safety to be protective of 

 human and animal health. But action levels denote specific levels of contamination at which 

 the agency is prepared to take regulatory action. 



I'll come back to the uncertain regulatory environment that gripped our industry in 

 a few moments. 



Witfi a non-carcinogenic mycotoxin like vomitoxin, the grain handling industry must 

 balance several considerations. These include the quality needs of end-users, FDA's 

 regulatory policy and elevator managers' desires to provide a £ur market for their farmer- 

 customers. 



The degree to which each of Aese considerations is met depends on such critically 

 important fiunors as the extent of weather-damaged grain; the expected ratio of high-quality 

 to low-quality grain, market demand for various qualities and available storage space. 

 Elevator managers also issess prudent storage and market risks to minimize the possibility 

 of severe financial loss. Finally, elevator managers must cope with each of these 

 considerations and fiictors under the tight time constraints of eariy harvest pressure. And as 

 I mentioned earlier with respect to vomitoxin, this year's situation was compounded by an 

 uncertain regulatory environment. 



