16 
modification as the language of these sections is ambiguous; it is not clear 
whether the organisms must be killed in the fermentation vessel or if they may 
be' killed during processing. 
Dr. McKinney said that in his interpretation, a closed system is one frcm \^\ich 
no release of organisms into the environment or work place occurs. Dr. Waitz 
asked if a primary system could be defined as a fe men tor attached by hard 
piping to several pieces of processing equipment. Dr. McKinney said such a 
system could be considered the primary container; the integrity of the piping 
should, however, be certified. Dr. Waitz asked if a closed roan with negative 
pressure might be considered a primary system. Dr. McKinney replied that 
architectural and mechanical features are secondary containment barriers. He 
said he would not consider a roam a closed system and, thus, would not consider 
it primary containment. Dr. Berns pointed out that workers would enter the 
roam, so the organisms are not isolated from the environment. Dr. Waitz asked 
if Dr. McKinney would consider the room the primary containment system under 
P4 conditions. Dr. McKinney said he would not. The roam is a secondary barrier 
in a P4 facility; the glove box provides primary containment. 
Mr. Galliher of Biogen, Inc., said industrial firms would like to grow an 
organism in a fermentor, and at the end of the growth period, pipe the culture 
to a centrifuge, then to a homogenizer, and finally to a holding tank. The firm 
would like to handle the culture in this way without killing the culture in the 
fermentor. Cultures inactivated in the fermentor provide the protein chemist 
with a "boiled egg" mixture, magnifying purification problems and frequently 
inactivating the desired product. Mr. Galliher asked if the NIH would 
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