51 



an adulterant from food; therefore, FDA under normal cir- 

 cumstance, would not condone the use of blending. 



However, we felt that the situation in Missouri is not normal; 

 and this is due to the fact that this past summer they suffered 

 some very severe climatic conditions — the heavy rains, the floods, 

 the drought — all of which are conducive to the production of 

 aflatoxin. 



So in responding to Missouri's request for guidance, we first stat- 

 ed that the FDA action levels that are in effect should serve as a 

 primary means of controlling aflatoxin-contaminated corn. And we 

 also assured the State at that time that we would fully support 

 their use of these action levels for controlling aflatoxin-contami- 

 nated corn in the State of Missouri. 



According to the State, however, Missouri farmers could still suf- 

 fer major price reductions in the sale of com that may contain 

 aflatoxin and that the FDA action levels themselves were not pro- 

 viding the necessary relief that they felt the farmers were entitled 

 to. 



Accordingly, we did write the State of Missouri and told them 

 that if proper precautions are maintained, FDA likely, would not 

 object to the use of blending for controlling this particular problem. 



This letter was sent to the State of Missouri, department of agri- 

 culture on September 16, 1993. 



That closes my opening statement, Mr. Chairman. My colleagues 

 and I will be happy to answer any questions that you may have. 



Thank you. 



[The prepared statement of Mr. Wessel appears at the conclusion 

 of the hearing.] 



Mr. Johnson. Thank you, Mr. Wessel. 



Were you, or are you, involved in any type of interagency work- 

 ing group, either formally or informally, that worked on the up- 

 dated advisory levels on vomitoxin? 



And do you think you are equipped to deal with emergency situa- 

 tions like this? 



There has been some question about the length of time that it 

 took to react to this current situation. 



Mr. Wessel. We are experienced in dealing with food contamina- 

 tion problems. I think, you have to understand, that is our primary 

 mission in enforcing the Federal Food, Drug, and Cosmetic Act. 

 Our primary concern in all cases is the protection of the public 

 health. 



At the same time, we are frequently confronted with emergency 

 situations, such as that occurred this year, both in the Upper Mid- 

 west as well as in Missouri; and I think we are mentally geared 

 to deal with those kinds of situations. 



At the same time, we do not work in a vacuum. We certainly co- 

 operate with our sister regulatory agencies, such as the U.S. De- 

 partment of Agriculture. We also have immediate contacts with 

 Government researchers in other countries. And we do have close 

 and very active cooperation with State agencies, as well as indus- 

 try. 



Mr. Johnson. At this point, you see no need to formalize those 

 relationships more so than they already are? 



