SUSAN WRIGHT 
1517 SHADFORD ROAD 
ANN ARBOR. MICHIGAN 46104 
Telephone ( 313 ) 769-2606 
September 21, 1978 
Dr. Donald S. Fredrickson 
National Institutes of Health 
Bethesda, MD 20014 
Dear Dr. Fredrickson: 
I do not think that the general direction of proposed revisions 
to the NIH guidelines for recombinant DNA research is justified. The pri- 
mary defense of these revisions, as reflected in your introduction to them, 
has been that there is now evidence which shows that the risks from recombi- 
nant DNA activities are less than was originally thought to be the case. Yet 
analysis of this evidence shows that there are many questions concerning its 
validity. Specifically: 1) The Falmouth conference reached consensus on a 
single point, namely, the improbability of converting the K-12 strain of 
E.coli into an epidemic pathogen. The possibilities of converting E.coli 
into a non-epidemic pathogen or of transfer of foreign genes to other strains 
were not ruled out. Indeed, NIH is funding a variety of risk assessment 
experiments to try to answer questions that were raised at Falmouth about 
the survival potential of E.coli K-12 and the probability of transfer. The 
proposed revisions are based on the assumption that the transfer experiments 
will yield negative results. As one commentator noted in testimony at the 
hearing, this is not only bad science: it is also bad administration. 
2) The Ascot meeting on the risks of use of virus DNA was held in private: 
not even members of the British GMAG let alone scientists in the U.S. who 
have felt that a more conservative recombinant DNA policy was desirable 
were invited. The results of the Ascot meeting and the Bethesda meeting 
which followed it have not been published or discussed in open scientific 
meetings. It is therefore impossible to judge the validity of the con- 
clusions that were reached. (Certainly it seems unlikely that members of the 
Ascot meeting would have approved the further whittling-down of containment 
levels that occurred at the Bethesda meeting.) 3) The argument that 
because no harm has occurred, recombinant DNA activities are safe involves 
a triple fallacy: a) since workers are not being monitored, we actually 
do not know what the effects of work with recombinant DNA are. b) If 
effects of recombinant DNA activities have a long latency period, they would 
not have been detected by this time, c) As several witnesses at the 
hearing pointed out, the argument confuses the ability to safely perform 
a process with the intrinsic hazard of the process itself. We surely 
would not want to have such arguments used in defense of removal of safeguards 
from nuclear power plants or from work on Q-fever. 
While valuable protection might be lost by relaxing the guidelines, 
nothing would seem to be gained by doing so. As Norton Zinder pointed out 
in his testimony: 
The great promise of research with recombinant DNA has been and 
continues to be fulfilled. Numerous significant advances in our 
knowledge of basic biology have been made. Sooner than we had any 
right to expect the work will yield useful products. ' The current 
literature abounds with its success. 
[A-226] 
