Page -6- of Attachment C 
BIOLOGICAL CONTAINMENT , FOLLOWING THE NIH GUIDELINES, THERE 
SHOULD BE LITTLE DANGER FROM THE PROCESSES DESCRIBED ABOVE. 
In fact, production-scale operations may be safer than those 
IN THE LABORATORY, BECAUSE: 
o Heavy stainless vessels are used, rather than glass. 
o Complete containment is used for any transfer operations. 
o Rapid sterilization is possible in case of a procedural 
MISTAKE. 
SUMMARY 
Containment and other safety procedures have low© been 
STANDARD FOR BOTH FERMENTATION AND PETROCHEMICAL PROCESSES, ON 
A PLANT SCALE. ACCIDENTS ARE EXTREMELY RARE IF ESTABLISHED 
PROTOCOLS ARE FOLLOWED. HOWEVER, IF THE REMOTELY POSSIBLE HAPPENS 
( E . G . , FAILURE OF AUTOMATIC CONTROLS, RUPTURE OF METAL REACTION 
VESSELS, ETC.), CATASTROPHE CAN RESULT. BECAUSE LESS EXTREME 
CONDITIONS EXIST WHEN LARGE-SCALE FERMENTATION REACTIONS ARE 
CARRIED OUT THAN PREVAIL FOR MANY STANDARD PETROCHEMICAL PROCESSES 
PRODUCING THE SAME PRODUCTS, CATASTROPHIC ACCIDENTS ARE LESS LIKELY 
IN THE FORMER CASE. HOWEVER, IN LARGE-SCALE REACTIONS INVOLVING 
RECOMBINANT DNA PROCESSES, THE INDICATIONS ARE THAT EXTRAORDINARY 
PRECAUTIONS ARE BEING TAKEN TO AVOID THE ESCAPE OF ANY VIABLE 
ORGANISMS, AND TO COMPLY WITH THE NIH GUIDELINES. 
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