126 



6 



implemented by grain elevators — are part of the multi-layered safeguards that exist within 

 the grain handling and processing industry and affect decisions on weather-damaged grain 

 that is purchased from fanners. 



In addition, the U.S. Department of Agriculture's Federal Grain Inspection Service 

 has issued regulations that require all grain exported from the United States that is officially 

 inspected to be tested for the presence of aflatoxin unless the buyer and seller contractually 

 agree to waive this requirement. In addition, FDA has established regulatory policies that 

 govern the Food, Drug and Cosmetic Act's export provisions governing contaminants. 



Vomitoxiii 



The regulatory framework governing aflatoxin has been in place for many years and 

 is well understood by our industry. But a similar certainty did not exist until very recendy 

 concerning FDA's current regulatory stance on deoxynivalenol, commonly referred to as 

 vomi toxin. 



This non-carcinogenic toxin is produced by several molds of the genus Fusarium . 

 especially F. graminearum . which causes pink scab disease in wheat. If weather conditions 

 develop similar to those that existed in the Midwest in the spring and summer this year, it 

 is virtually impossible to completely avoid the presence of DON in wheat. 



Since 1982, our industry has operated under a set of advisory levels issued by FDA, 

 which expressly stated that the agency was "not prepared to take regulatory action at these 

 levels but do(es) believe that products at or below these levels should not present a public 

 health hazard. ' 



But in early August, it became widely known in our industry that FDA was revisiting 

 its 1982 advisory levels, given the availability of new toxicological studies concerning the 



