89 



2 

 area becoming contaminated. The conditions for this mold growth 

 and toxin production may also exist in other parts of the 

 country. 



The agency first issued guidance to State and industry officials 

 in 1982 that described levels of vomitoxin in wheat and wheat 

 products that we believed would not present a public health 

 hazard. This advice was based on the limited toxicological data 

 that were available at that time. Since then, additional data 

 have become available, including reports of outbreaks of 

 vomitoxin-associated acute gastrointestinal illness in humans in 

 China (1984 and 1985) and in India (1987). Although 

 uncertainties exist concerning the precise role played by 

 vomitoxin in these outbreaks, the data provide a clearer picture 

 of the effects vomitoxin may have on human health. 



On the basis of this new information, FDA updated its advisory 

 levels for vomitoxin in wheat products intended for human 

 consumption (e.g., flour) and in wheat and other grains used as 

 animal feed. This revised guidance continues to be protective of 

 the public health, and also is responsive to the need for 

 guidance being expressed by State officials and industry. 



The updated advisory levels were sent to State and trade 

 associate officials on September 16, 1993 and are appended to my 

 statement . 



