similar to the operations involved in fermentation of biotech- 
nology products and provide an information base which we believe 
is very relevant to large-scale rDNA experiments. Many of our 
members have extensive experience in antibiotic and other large 
scale fermentation processes; others have employed as experts 
persons with extensive pharmaceutical experience in this area. 
Also, the IBA represents a forum in which significant aspects of 
industrial expertise can be shared among our members. It is our 
belief that the present industry standards represent a high level 
of care which exceeds that necessary for the kinds of experiments 
which are presently being carried out or contemplated at large- 
scale levels. 
2 . Problems with Present Large Scale Recommendations . 
Our experience has indicated that the present Physical 
Containment Recommendations for Large-Scale Uses of Organisms 
Containing Recombinant DNA Molecules are reasonable and workable, 
although they are quite stringent for work at the Pl-LS level. 
The design requirements in the Recommendations make sense to us 
and are consistent with other regulations relating to the 
manufacture of products for use with human subjects. 
While it has not yet been a problem for IBA members, we 
believe there are potential difficulties arising from the 
requirement in Section VII-B-2 of the Recommendations that the 
primary containment system not be opened until all microorganisms 
are inactivated. To the extent that this requirement means that 
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