Dr. William J. Gartland, Jr. 
January 31, 1984 - Page 2 
has been extremely rapid. During these advances, the scientific 
community has turned to the NIH for help in organizing the best 
source of expertise to deal with the scientific and technical 
questions raised by the research with the assurance that the public 
interest also has been responsibly represented. The RAC, in its 
several years of existence, has established expertise among its 
members, advisors, and consultants that is unparalleled in its 
ability to deal with the diverse problems 
in recombinant DNA technology. 
Restated below are the questions posed in Section II of the 
notice together with the company's comments. 
1. Should the NIH Guidelines be limited strictly to work 
done in the laboratory? 
We recommend continuation of the present Recombinant 
DNA Advisory Committee oversight of recombinant DNA 
technology. Further, we urge continued voluntary 
adherence to the guidelines by industry and other 
non-funded groups participating in recombinant DNA 
research. 
It is important to note that the basic scientific 
concepts that are involved in recombinant DNA tech- 
nology are the same regardless of the particular 
application or scale; functionally identical recombi- 
nant DNA laboratories exist both in the university 
environment and in industry. Historically, the 
10-liter volume limit used to differentiate large- 
scale from laboratory operations was arbitrarily 
selected; several of our previous presentations before 
the RAC and the Large-Scale Working Group have 
emphasized the fact that increased fermentation volume 
does not equate with increased risk. The construction 
and use of recombinant organisms is a common theme 
that allows the exchange of knowledge and experience 
in one area with that in another — a process which has 
been greatly facilitated by the existence and function 
of the RAC. 
2. Should NIH accept for review only individual proposals 
funded by NIH or only proposals funded by the Federal 
government? 
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