doing business in a way that ensures safety of the environment, 
the community, and our workers, and we believe that adherence to 
these guidelines is an important part of that commitment. We 
also believe that compliance with these guidelines provides for 
reassurance of the communities in which we work and this serves 
to benefit the technology as a whole. While we have generally 
found the guidelines both reasonable and workable, there are some 
modifications which we would suggest. 
Our first comment pertains to the Guidelines for Research 
Involving Recombinant DNA Molecules (47 FR 38048-38068). 
Schering-Plough supports the concept of IBC review and 
approval of recombinant DNA facilities and practices. 
However, in order to provide greater flexibility during 
scale-up, we suggest that the exception to Appendix C-II, 
C - 1 1 1 and C-IV requiring prior IBC review and approval of 
large scale experiments using exempted E. coli K-12, 
Saccharomyces cerevisiae and Baci 1 1 us subti 1 i s Host Vector 
Systems be changed. An acceptable modification would require 
notification of the IBC simultaneously with the initiation of 
experiments where IBC-approved practices and an IBC-approved 
Pl-LS containment facility are used. 
Accordingly, we propose the following language changes for 
the Guide! ines : 
Part III-B-5 Experiments involving more than 10 liters of 
culture. The appropriate containment will be decided by the 
IBC except where exempted under Section III-D-5*. Where 
indicates proposed changes in wording. 
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