PREFACE 
On June 2 3, 1976, the Director, National Institutes of Health (NIH), 
with the concurrence of the Secretary of Health, Education, and Welfare 
and the Assistant Secretary for Health, issued guidelines that govern 
the conduct of NIH-supported research involving recombinant DNA 
molecules. These guidelines appeared in the Federal Register, July 7, 
1976 (41 FR 27902 et seq. ). The NIH conducted an environmental impact 
assessment and prepared a Draft Environmental Impact Statement in 
accordance with the National Environmental Policy Act of 1969. A Draft 
Environmental Impact Statement on the Guidelines was published in the 
Federal Register for public comment on September 9, 1976 (41 FR 3842 5 
et seq. ). 
In recombinant DNA experiments, "genes "--deoxyribonucleic acid 
(DNA) molecules --from living organisms can be transferred to single 
cells from completely unrelated organisms. These experiments depend 
on the ability to join genetic material from different sources and to 
propagate the resulting elements in single bacterial and animal cells. 
The new recombinant DNA technique has resulted in a profound and 
qualitative change in the field of genetics. Developments in genetic 
research, particularly in the last 4 years, open avenues to science 
that were previously inaccessible. Hypotheses and ideas that were not 
testable can now be rigorously investigated. Understanding of basic 
biological phenomena has already been enhanced, and the promise of 
recombinant DNA research for better understanding and improved 
treatment of human disease is great. Further experimental data will 
be required to delimit the benefits that may be derived through this 
technique . 
There is also a possible risk that microorganisms with foreign 
genes could cause disease or adversely affect the environment if they 
should escape from the laboratory and infect human beings, animals, 
or plants. Many recombinant DNA experiments have been conducted 
throughout the world during the past 5 years and are continuing. To 
date, no known hazardous organism has been produced in this work. 
Thus, the risk of converting harmless organisms to harmful ones by 
recombinant DNA experiments remains hypothetical. Further work 
will eventually determine the limits of these hypothetical risks. 
A Federal Interagency Committee on Recombinant DNA Research 
recommended in March 1977 that legislation be passed to extend the 
standards of the NIH Guidelines to all recombinant DNA activities in 
the public and private sectors. On the basis of these recommendations, 
Joseph A. Califano, Jr. , Secretary of Health, Education, and Welfare, 
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