DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OF HEALTH 
SCTHISOA. MARYLAND 20014 
December 17, 1979 
Dr. Donald Fredrickson 
Director, NIH 
Dear Don, 
This letter is to give my wholehearted support to the new 
version of the guidelines for recombinant DNA research, in particular 
the downgrading of K-12 containment requirements. There are three 
comments that I would like to make. 
1. The requirement for prior IBC review and approval of experiments 
involving expression of eukaryotic proteins in K-12 is in my view 
superfluous, and is almost guaranteed to cause nuisance and confusion 
for investigators and IBC's. Many IBC's will understand this section 
to imply that they must require higher containment for such experi- 
ments, and for this the guidelines give no guidance or clarification. 
This requirement will expose many investigators to arbitrariness and 
unneccessary restrictions. 
This requirement is superfluous for two reasons. First, it 
implies a significant uncertainty about the inherent safety of the K-12 
systems, which is no longer a valid concern. Second, it does not take 
into account the lag between Initiation of experiments and the achieve- 
ment of an expressing clone. For a new project, the notification of 
the local IBC as required for all K-12 work provides full opportunity 
for the IBC to review the proposal well before the expressing clone is 
in hand. For a change in an ongoing project, or for work with an 
expressing clone to be received from another laboratory, notification 
of the IBC, calling this to their attention, should be adequate. Prior 
approval seems quite out of proportion the possibility of risk. 
In any case, the guidelines should clarify the intent of this 
requirement and should explicitly state that PI containment is 
recommended for all expressing clones except those that have a significant 
likelihood of producing a potent toxin. 
2. I originally urged exemption of the K-12 experiments from the guide- 
lines, and still feel that this is justified on scientific grounds. 
However, there is one aspect of leaving them under the guidelines that 
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