UNIVERSITY OF MINNESOTA 
TWIN CITIES 
Boynton Health Service 
410 Church Street S.E. 
Minneapolis, Minnesota 55455 
January 9, 1978 
Donald S. Fredrickson, M.D. 
Director 
National Institutes of Health 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
This is to follow-up on your request at your advisory committee meeting on 
December 15 and 16, 1977, for comments on the proposed revision of the NIH Recom- 
binant DNA Guidelines, printed in the September 1977 "Federal Register." I 
appreciated the opportunity to participate on the advisory committee and am par- 
ticularly grateful to be able to provide a somewhat more thoughtful analysis of 
the proposed guidelines, after having had some time to reflect upon the proceedings 
of the meeting. 
The following are my comments and suggestions, proceeding from the more 
general to the more specific: 
1. OVER-ALL IMPRESSION ABOUT PROPOSED CHANGES- Although I will provide some 
specific suggestions later, I generally concurred with the proposed changes in the 
guidelines. I make this statement because I feel, on the basis of information 
presented by various witnesses (both for more stringent and less stringent guide- 
lines), that the current recommendations for changes in guidelines represent a very 
cautious and small step toward relaxation of containment requirements. 
2. THE ACUTE NEED FOR RISK ASSESSMENT EXPERIMENTS- Although it is not com- 
pletely clear to me from the committee deliberations, it appeared that substantive 
risk assessment experiments have not gone forward because of some problems with 
unrealistic requirements in the present guidelines. It seems to me that risk 
assessment experiments are extremely important for the following reasons: (a) 
protection of the public from hazards which may exist with the new technology; 
(b) establishing public confidence in the scientific community's understanding of 
potential hazards associated with this new technology; (c) providing for the 
orderly progress toward future revisions of these guidelines; and (d) eventually 
reducing the cost of this research. It is my perception that your opportunity 
to prudently apply the variance provision in the proposed guidelines will remove 
a significant barrier now preventing conduct of risk assessment experiments. I 
believe this adds considerable incentive for adoption of this provision of the 
proposed guidelines. 
A further word about cost of research; it seems to me that the economic 
implications of not knowing a risk are significant. As I was reflecting upon this. 
[Appendix A — 202] 
