5 
tection Agency; a panel made up of David Baltimore, Ph. D., of the 
Massachusetts Institute of Technology; Halsted Holman, M.D., of the 
Stanford University Medical School ; Norton D. Zinder, Ph. D., of the 
Rockefeller University ; and Robert Sinsheimer of the California In- 
stitute of Technology; another panel made up of C. Joseph Stetler, 
President of the Pharmaceutical Manufacturers Association (PMA) ; 
John G. Adams, Ph. D., Vice President for Scientific and Professional 
Relations, PMA : and Sidney Udenfriend, Ph. D., Vice President and 
Director of the Roche Institute of Molecular Biology; and Burke K. 
Zimmerman, Ph. D., of the Environmental Defense Fund, Washing- 
ton, D.C. 
Dr. Fredrickson, Director of the NIH, described the potential risks 
and benefits associated with recombinant DNA research, and noted 
that the object of the NIH guidelines is to minimize potential risks. He 
discussed the way the guidelines were developed and explained their 
intent. Dr. Fredrickson indicated that : 
. . . recombinant DNA research has strong potential in 
medicine as well as in science and technology generally. In 
medicine it is capable of providing hitherto unobtainable 
knowledge of the organization and expression of genes in 
health and disease. It possibly may also permit economical 
production of important meclicinals. Potential benefits in ag- 
riculture and industry include more abundant crops and syn- 
thesis of industrially important biochemical agents such as 
enzymes. There are risks, however, as well as potential bene- 
fits in this new research. For example, bacteria with trans- 
it] anted genes may prove hazardous to man or other forms 
of life. Like many of the potential benefits, these risks remain 
speculative, for there is still scanty evidence that genes from 
one form of life can be expressed in any other form. We must 
assume, however, that they may be. Thus, our present state 
of knowledge dictates strict controls on this form of experi- 
mentation. The NIH guidelines prohibit certain types of ex- 
periments — those, for instance, that might produce disease 
germs with increased resistance to antibiotics. Other experi- 
ments will go forward under special safety conditions. The 
guidelines have a definitive administrative framework for as- 
suring that safety is an essential and integrated component 
of research involving recombinant DNA molecules. 
Dr. Talley, representing EPA, commented on the potential environ- 
mental impact of the research : 
Although the risks of recombinant DNA research appear 
to be low, the consequences of an untoward event could be cat- 
astrophic. Prudence dictates that we proceed with extreme 
caution in this area of research. 
The first panel consisted of Drs. Baltimore, Zinder, Sinsheimer and 
Holman. They discussed the adequacy of the guidelines. The panel 
focused on the appropriate role for the participation of representatives 
of the public in recombinant DNA decision-making processes. The 
panel discussed the idea of expanding the authority of the National 
Commission for the Protection of Human Subjects of Biomedical and 
Behavioral Research in this area. Dr. Burke Zimmerman, with the 
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