AftCA COOK IOI 
PHONC 342-2177 
MEDICAL CENTER 
McARDLE LABORATORY 
FOR CANCER RESEARCH 
UNIVERSITY OF WISCONSIN • MADISON, WISCONSIN 53706 
November 8, 1977 
Dr. Donald S. Fredrickson, Director 
National Institutes of Health 
Bethesda, MD 20014 
Dear Dr. Fredrickson: 
As a former member of the Advisory Committee, who is not performing 
novel recombinant DMA research, I would like to make a few comments and 
suggestions pertaining to the Proposed Revised Guidelines as published in 
the Federal Register 42 No. 187 of September 27, 1977, pp. 49596-49609. 
The area covered by the Guidelines can be divided into research employing 
(A) E_. col i K- 1 2 host-vector systems and (B) other host-vector systems. 8ased 
on the data presented in the "Curtiss letter" and the conclusions of the 
Falmouth Meeting there is no real justification to include most novel recombinant 
DNA activities employing systems (A) , i ,e. , E_. col i K~ 1 2 EK1 or EK2 host-vector 
systems, into the Guidelines. This is what we meant by stating in the Intro- 
duction that "the revised Guidelines continue to be deliberately restrictive, 
with the intent of erring on the side of caution". However, I have grave 
doubts whether scientists or the U. S. Government, represented by the N.I.H., 
have a right to "intentionally err" just to accommodate irrational fears, 
concerns and politically motivated considerations. 
There are two solutions to this dilemma. One would be just to modify or 
eliminate the words '“with the intent of erring" without changing the Guidelines. 
This would be a very wrong solution even if the present Committee could be 
persuaded to change the wording. It was a unanimous decision after long 
deliberation and new members would not be aware of all the reasons for this 
statement. The second solution would be to change the statement "with the 
intent of erring", but at the same time to exclude from the Guidelines all 
novel recombinant DNA activities employing E_. col i K-12 EK1 or EK2 host-vector 
systems, with the exception of (1) those DNAs listed in IIIA, (2) DNAs derived 
from true pathogenic strains of class 2 (Appendix B) , and (3) DNA from organisms 
known to produce hazardous polypeptides (toxins or other agents of pronounced 
biological activity and known to be highly active when ingested). 
[Appendix A — 46] 
