MEMORANDUM 
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OF HEALTH 
Director, NIAID 
Through: Acting Deputy Director, NIAID 
DATE: May 5, 1976 
Acting Scientific Director, NIAI 
Chief, Laboratory of Viral Diseases, NIAID 
M.T2JECT: NIAID Risk Evaluation Program on Recombinant DNA Molecules 
As you know, the NIH guidelines for research on recombinant DNA molecules 
will be issued in the near future. In large part, the great difficulties 
faced by the NIH Recombinant DNA Program Advisory Committee in devising 
these guidelines was due to the absence of relevant data on what the risks 
might be. The guidelines are considered by many, including me, to repre- 
sent a very conservative, stop-gap mechanism which is temporary, pending 
the acquisition of data which will either allow relaxation of containment 
or will substantiate the existence of a real biohazard. In my opinion, 
the success of the guidelines will depend initially on the good will and 
sense of fairness of the scientists interested in doing such research, and 
subsequently (after a year or two) on their own evaluation of whether the 
restrictions are really indicated. I strongly suspect that within two 
years after issuance of the guidelines, if there is no concrete evidence 
that a biohazard can develop, violations will be so rampant that heavy 
handed external regulation will be imposed. The problems that this would 
entail, plus the polarizations that would develop between different groups 
of scientists, and between scientists and legislators, would produce 
disastrous consequences for NIH.. 
Accordingly, I see it as a matter of much urgency that NIH assume the 
responsibility of ensuring that the evaluation of possible risks be done 
in an expeditious, competent, and visible manner. 
To date, the collection of data on risk has been fragmented and rather 
haphazard. Some of the laboratories working in bacterial systems have 
looked at colonization of people by K-12, the occurrence of A-sensitive 
E. coli in man, and, of course, the ability of E. coli to translate 
eukaryotic DNA; however, these are not part of any coordinated program. 
The polyoma-E. coli experiment of Malcolm Martin and me also represents 
a significant step in this direction, but it is only a small part of the 
needed research. One relevant initiative of the Program Advisory Committee 
was the appointment, in December 1975, of a subcommittee consisting of 
Drs. Szybalski (Chairman), Hogness, Spizizen, and me, to deal with risk 
evaluation. Our subcommittee has not been able to examine the problem, and 
I do not think that a widely dispersed subcommittee could be expected to 
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