QlCrufeb J&enafe 
WASHINGTON. DC. 20310 
February 14, 1977 
Dr. Richard Donovick, Director 
American Type Culture Collection 
12301 Parklavn Drive 
Rockville, Md. 
Dear: Dr. Donovick: 
As you know, the conduct of recombinant DNA research has become the subject of 
increasing debate and concern both within the scientific community and more recently, 
in public forums. The Subcommittee on Health has maintained an intense interest in the 
issues which have prompted the controversy over such research and has held two public 
hearings concerning these issues over the past two years. 
At the last hearing on September 22, 1976, the Director of the National Insti- 
tute of Health, the Assistant Administrator for Research and Development of the Environ- 
mental Protection Agency, a nanel of eminent scientists, and the President of the Phar- 
maceutical Manufacturers Association, provided thoughtful testimonv concerning the 
status of recombinant DNA research and the guidelines recently promulgated by the 
National Institute of Health for the conduct of such research. As expressed by the 
Director of NIH, the object of the guidelines is to minimize the associated risks while 
permitting appropriate tynes of this research to continue with its great potential bene- 
fit to mankind. 
The NIH guidelines are now being adopted by all federal agencies conducting or 
supporting such research. Mr. Joseph Stctler, the President of the Pharmaceutical 
Manufacturers Association stated at the subcommittee hearing that pharmaceutical com- 
panies intended to conform with the NIH guidelines and that the PMA would continue to 
work closely with NIH to work out minor problems so that compliance could be achieved. 
It was the consensus of the witnesses before the subcommittee that the NIH 
guidelines should be extended to all sectors of the research community conducting recom- 
binant DNA research, including the private sector and the international community. The 
subcommittee shares this view. 
We wrote to President Ford on July 19, 1976, oointing out the necessity for 
an extension and urging exploration of the means of implementation, including suggest 
legislation if necessary. President Ford's reply of September 22, 1976, indicated the 
the Interagency Committee on Recombinant DNA Research would be formed to review the 
activities of all government agencies performing or supoorting such research and to 
coordinate activities with non-federal institutions. The first meeting of the Inter- 
agency Committee was held on November 4, 1976 and there have been several subsequent 
meetings. The Committee has discussed, among other things, the need to establish a 
central registry of all recombinant DNA research and existing legislative authority 
regulation of such research. 
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