13 
Mr. Thornton recognized Et. Susan Wright. Er. Wri^t focused her connents 
on large-scale applications as she thought that v^ile many other issues are 
being addressed, the RAC was not adequately addressing that issue. She 
said the primary focus of RAC has been on the hazards of research, not the 
hazards of industrial processes. She said that one cannot dismiss change 
of scale with regard to accidental release of recombinant organisms. She 
felt the data base on industrial hazards is very poor. She said she had 
heard some industrialists in other countries were considering using open 
fermentatic«i tanks. If there is no oversight, companies will use viiatever 
fermentation process they think is in their best interest. There are 
irresponsible companies willing to cut comers and tate risks to try to 
gain a ocmpetitive advantage ever responsible companies. Furthermore, 
there are no risk assessment experiments with organisms making insulin, 
interferon, etc. She said the oemmittee is assuming that vhatever product 
is being made will be harmless. 
Dr. Wright said the RAC recommendation at the previous meeting to exenpt 
from NIH review, certain large-scale experiments utilizing ^ coli K-12, 
Saccharonyces oerevisiae and Bacillus subtilis host-vector ^sterns was an 
error vhich produced a major g^ in oversight. She urged the RAC to recon- 
sider and re-evaluate its oversight ever large-scale woric. 
Dr. Irving Jdinson of Eli Lilly and Company said that industry has produoed 
hundreds of gallcans of the causative agents of polio, diphtheria, whooping 
cough, etc., with no great hazard to workers or to the environment, and 
in fact with great benefit to the population. Dr. Johnson said the only 
open vats he is aware of are in the beer brewing industry. Most industrial 
fermentations are generally highly contained to protect against contamina- 
tion. Inocula are introduced into the growth tank through a rigid stainless 
steel structure. The connection does not leak and is steam sterilized. 
Dr. Wright said she was not making a categorical statement about hazards, but 
rather about the data base. In her opinion, the data are extremely poor and 
incomplete, and assunptions that problems will be uncomplicated or easy 
to deal with are premature. These new technologies should remain under 
RAC review until a better data base develops. 
Dr. Mason said that many industrial issues, though of concern, are beyond 
the scope of the RAC. Federal, state, and local authorities that make 
on-site inspections may wish to evaluate these issues, but RAC should not. 
Er. Ahmed felt a distinctioan should be drawn between organisn concentration 
and total amount in industrial processes. 
Dr. Gottesman said that the December 7, 1981, faroposal still requires that 
non-exempt large-scale procedures be reviewed by the local IBC before the 
project begins; Pl-IS containment would still apply. It extends to 
all large-scale experiments the conditions ^preved by RAC at the previous 
meeting for certain large-scale experiments. 
[342] 
