50 



nating grain grown in the Midwest this year and possibly else- 

 where. 



The first mycotoxin I will discuss is vomitoxin, which is produced 

 by various mold species that can be associated with the pink scab 

 disease affecting grain. 



The molds thrive in cool, wet conditions that occurred in the 

 Upper Midwest this past year. This resulted in some wheat from 

 that area becoming contaminated with vomitoxin. 



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 at the time would not present a public 

 health hazard. 



Since then, additional data have become available; and on the 

 basis of this new information, FDA updated its advisory levels for 

 vomitoxin in wheat products intended for human consumption. We 

 also updated the advisory for vomitoxin in wheat and grain when 

 used as animal feed. 



We believe that this updated advisory continues to protect the 

 public health, while at the same time provides the necessary guid- 

 ance that we believe the States and industry in the Upper Midwest 

 need in order to deal with this specific problem. 



The advisory levels were issued by FDA on September 16, 1993, 

 and are appended to my prepared statement. 



I would like to now briefly turn to the situation surrounding 

 aflatoxin. Aflatoxin is also a mold-produced toxin. It can occur in 

 food crops that are under stressed conditions, such as drought, fol- 

 lowed by extremely wet or heavy rain falls. 



It has been found in various kinds of food, and com, in particu- 

 lar, is susceptible — highly susceptible to aflatoxin contamination. 

 Aflatoxin is a known carcinogen in laboratory animals, possibly a 

 carcinogen in humans, and can cause severe liver damage when in- 

 gested at high levels. 



Based on our current understanding of aflatoxin toxicity, we be- 

 lieve that our longstanding action level of 20 parts per billion for 

 aflatoxin in com is sufficient to protect the public health and par- 

 ticularly humans. 



We also have an identical action level for aflatoxin contaminated 

 corn when intended for dairy cattle and for immature animals. The 

 available information also indicates that other kinds of food-pro- 

 ducing animals can be exposed to higher levels of aflatoxin, and ac- 

 cordingly we have adjusted our action levels to accommodate this 

 information. A list of the action levels that are current in effect for 

 aflatoxin in corn are appended to my prepared statement. 



Let me turn to the situation in Missouri. On September 10, 1993, 

 the Missouri Department of Agriculture wrote FDA requesting 

 guidance in dealing with what the State believes to be a serious 

 problem affecting its 1993 com crop with aflatoxin. 



The State asked FDA to support Missouri's use of blending. Let 

 me explain what blending is. Blending involves the mixing of 

 aflatoxin contaminated com with noncontaminated corn to produce 

 a blended mixture of com that could contain a level of aflatoxin 

 below some level that would be acceptable for feed use. 



The Federal Food, Drug, and Cosmetic Act, which we are respon- 

 sible for enforcing, clearly prohibits blending as a way of removing 



