SLOAN-KETTERING INSTITUTE for GANGER RESEARCH 
DONALD S. WALKER LABORATORY, 145 BOSTON POST RD., RYE, 
105 00 
/N 
OWENS 0-1100 
January 30, 1978 
Dr. Donald S. Fredrickson 
Director 
National Institutes of Health 
Building 1, Room 124 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
Periodic updating and reconsideration of the Guidelines for recombinant 
DNA research is a necessary activity and we are glad to see that the 
process is taking place. The Guidelines address themselves to only one 
facet of the recombinant DNA question, however, and many members of the 
scientific community feel that there are broader issues to be considered. 
Unfortunately there has been no opportunity in the recent hearings on 
Guideline revisions to address these questions. I would like to point out 
three fundamental problems which are of serious concern to a number of us. 
These broad problems do not entirely fall within the purview of the NIH 
and would be more properly addressed by legislation. They are: 
1. The responsibility for formulating, revising and granting exemptions 
from the Guidelines is vested in a small group, within the NIH, which is 
oriented toward biomedical research. Although the Committee is free to 
consult experts in other fields, there is no mechanism for assuring compre- 
hensive and committed consideration of potential problems that could result 
from recombinant DNA technology in other areas, such as ecology. One cannot 
expect ecologists and others who are not now professionally involved with 
recombinant DNA to be sufficiently cognizant and conmitted to analysing the 
problem unless they are officially recruited and charged with public respons- 
ibility. Some means is also needed for integrating the views of the various 
experts so that the public interest will dominate. In short, since the 
NIH is a specialized body concerned with the development of the biomedical 
sciences it is inappropriate for dealing with the regulation of recombinant 
DNA activities. 
2. Universal application of the Guidelines, and a method of enforce- 
ment, are lacking. Without these the Guidelines cannot be really meaningful. 
3. No controls have been set up governing the future non-research 
usages of recombinant DNA technology. Although the NIH offers to seek the 
concurrence of other concerned government agencies before granting permission 
for release of recombinant organisms into the environment, this arrangement 
is far too loose and casual. The public interest requires a concerted study 
of the potential dangers of every proposed industrial application of the 
technology, before it is undertaken, as well as continued monitoring. Be- 
cause of the large scale of industrial technology as opposed to research, 
RESEARCH UNIT OP MEMORIAL SLOAN-KETTERING CANteSP^fi^^R 
[Appendix A — 229] 
