American Medical Association 
535 NORTH DEARBORN STREET • CHICAGO, ILLINOIS 60610 • PHONE ( 312 ) 751-6000 • TWX 910 - 221-0300 
JAMES H SAMMONS, M 0. 
Executive Vice President 
( 751 - 6200 ) 
September 25, 1978 
Donald S. Fredrickson, M. D. 
Director 
National Institutes of Health 
Bethesda, Maryland 20014 
Re: "Recombinant DNA Research, 
Proposed Revised Guidelines"; 
as published in the Federal 
Register on July 28, 1978 
(43 F.R. 33042) 
Dear Doctor Fredrickson: 
The American Medical Association takes this opportunity to 
comment upon proposed revised guidelines for the conduct of 
recombinant DNA research that is either supported by the National 
Institutes of Health (NIH) or conducted at an institution where 
NIH supported recombinant DNA research is also being conducted. 
The proposed revised guidelines are designed to update and improve 
upon NIH's original recombinant DNA research guidelines published 
in 1976. 
There has been a significant amount of activity concerning 
regulation of the way recombinant DNA research is conducted. This 
activity developed in response to concerns expressed by scientists 
and interested laypersons regarding the potential risks to the 
environment posed by recombinant DNA research. In the period 
prior to the issuance of the NIH guidelines, it was speculated 
that an accidental release or discharge of recombinant DNA organisms 
or possible "super pathogens" (resistant to known physical defenses 
and with no known natural antagonists) could endanger the environ- 
ment or the whole human race. It was in this atmosphere that NIH 
imposed its initial guidelines. At that time, NIH fully intended 
to revise and restructure its guidelines as new information 
regarding the risks and the benefits involved in the recombinant 
DNA research became available. 
The regulation of recombinant DNA research can be justified 
as necessary to protect the public health and safety. However, the 
regulation of recombinant DNA research, as with the regulation of 
any basic scientific inquiry, must not be allowed to become so 
[A-362] 
