Dr. William J. Gartland 
National Institutes of Health 
February 1, 1982 
Page 4 
A few additional comments concerning IBA's recommendations are offered 
for your consideration. 
First, IBA believes that industry is committed to continued adherence to 
the NIH guidelines as modified. Such responsible participation in recombinant 
DNA research and application has been an accepted tradition in the biotechnology 
industry, and continues to receive wide industry support. One significant 
reason for adherence to a uniform system of federal guidance and overseeing 
is our belief that such an approach is more compatible with commercial develop- 
ment and the benefits it brings to society than would be a system of varying 
local requirements. In its decisional process concerning this and future 
guideline revisions, NIH should solicit and weigh credible information on pro- 
posed changes from other cognizant governmental units. 
Next, the combined modified guidelines that we recommend should contain 
a preface which expressly articulates the safety judgments that underlie the 
detailed decisions reached. This section should make explicit NIH’s confid- 
ence in the safety of recombinant DNA activities today and the desirability of 
encouraging its development for the anticipated contribution to the public 
welfare. It should also indicate clearly that, when they were created, the 
guidelines were intended to be modified from time to time as experience 
accumulated; and that the decision reached in this instance was taken after 
careful consideration as well as after substantial opportunity for public 
input. 
Additionally, we would emphasize that an effective IBC is the foundation 
of our proposed institutional guidance system. As in the past, it is antici- 
pated that IBC's would make substantive contributions to ongoing activities 
at a minimal cost of bureaucratic requirements and delays. They are desir- 
able from the standpoint of contributing to employee protection by heightening 
employee awareness of good laboratory practices; their monitoring activities 
assist in documenting safety records and compliance with the guidelines, as 
well as in identifying occasional problems which may profitably be addressed 
at the RAC/NIH level. Large scale industrial projects seeking approval would 
appropriately be handled by IBC's, since their consideration would provide 
adequate review with less chance of risking exposure of confidential and pro- 
prietary material than if the material were in the possession of the government. 
The RAC, while reviewing fewer activities as a matter of course, would also 
continue to address itself to problem areas identified by IBC's, to guideline 
revisions as might appear appropriate, and to overseeing continued work in the 
recombinant DNA risk assessment area. In our view, it would continue to be a 
valuable resource in the federal guidance system. 
Lastly, we would note briefly that we believe it time to reevaluate the 
10 liter threshold for triggering review of scale-up applications. The 10 liter 
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