Or. William J. Gartland 
National Institutes of Health 
February 1, 1982 
Page 5 
designation has a historical rather than a scientifically logical basis, and is 
outmoded In an era of growing industrial applications, in which the feasibility 
of large scale production will first be investigated with smaller fermentations. 
In IBA's proposal, prior IBC approval is required for large production scale 
processes, even though the DNA activity will obviously have been performed pre- 
viously, and industry experience with scale-up of experiments is substantial. 
Moreover, other product regulatory requirements are likely to evolve. We there- 
fore believe that the necessity of seeking repetitive approvals during scale-up 
is clearly undesirable, offering little discernible benefit and, as commercial 
applications become more prevalent, unreasonably increasing costs. Accordingly, 
we suggest that the approval threshold initially be raised to a level of at 
least the 200 - 250 liter range. 
In conclusion, IBA appreciates the opportunity to comment on the proposed 
revision of the guidelines. We commend NIH for its thoughtful and considered 
approach to this task. We hope that our suggestions will be helpful in reach- 
ing a final decision, and we would be pleased to meet with NIH officials to 
discuss our position in greater detail, or to be of any further assistance in 
resolving the issues at hand. 
Sincerely 
HSP/sr 
Enclosure 
[757] 
