15 
B. Events Leading to Development of Guidelines 
On June 23, 1976, the Director, NIH, released "National Institutes 
of Health Guidelines for Research Involving Recombinant DNA Molecules" 
(see Appendix D). This action was approved by the Secretary of Health, 
Education, and Welfare and the Assistant Secretary for Health. The 
Guidelines establish carefully controlled conditions for the conduct of 
experiments involving the insertion of recombinant genes into organ- 
isms, such as bacteria. 
For about 3 years prior to the time the Guidelines were issued, 
recombinant DNA experimentation was carried out in the United States 
and abroad. Indeed, from the time scientists first expressed concern 
about the work, it has proceeded subject to restrictions adopted along 
the way, and much has been learned through use of the new technology. 
At no time has this scientific tool been banned completely. The heart 
of the controversy surrounding recombinant DNA is to define appropriate 
limits for application of the technology, which is new and might involve 
unknown risks. The chronology of events leading to the present Guide- 
lines and the decision to release them is as follows. 
It was some of the scientists engaged in recombinant DNA research 
who called for a voluntary deferral of certain kinds of experiments, 
in order to provide time to assess the risks and devise appropriate 
moratorium. " The capability to perform DNA recombinations, and 
the possibility that some such experiments might be hazardous, had 
become apparent at the Gordon Research Conference on Nucleic Acids 
in July 1973. Those in attendance voted to send an open letter to 
Dr. Philip Handler, President of the National Academy of Sciences, 
and to Dr. John R. Hogness, President of the Institute of Medicine, 
NAS. The letter, appearing in Science (7), suggested that the Academy 
"establish a study committee to consider this problem and to rec- 
ommend specific actions or guidelines, should that seem appropriate. " 
In response, NAS formed a committee, and its members published 
another letter in Science in July of 1974 (8). Under the title "Potential 
Biohazards of Recombinant DNA Molecules, " the letter proposed: 
First, and most important, that until the potential 
hazards of such recombinant DNA molecules have 
been better evaluated or until adequate methods 
are developed for preventing their spread, scientists 
throughout the world join with the members of this 
committee in voluntarily deferring the following 
types of experiments. 
. This limited voluntary deferral came to be called a 
