February 1, 1984 
Dr. William J. Gartland, Jr. 
Director, Office of Recombinant 
DNA Activities 
Building 31, 3B10 
National Institutes of Health 
Bethesda , Maryland 20205 
These comments are submitted in response to the questions raised by Dr. Bernard 
Talbot in Section II of the Federal Register notice. Genex Corporation endorses 
the response submitted by the Industrial Biotechnology Association and urges 
that the Recombinant DNA Advisory Committee (RAC) respond negatively to each of 
Dr. Talbot's questions. 
In the years since the scientific community elected to review and monitor the 
development of recombinant DNA technology, NIH and RAC have provided a consistent 
framework in which that oversight could be implemented and modified. The system 
has evolved as data accumulate showing the absence of risk and this has contributed 
to the orderly development of the technology while maintaining public confidence. 
As the applications of recombinant DNA technology reach the level of manufactur- 
ing and commercialization, it is Important for RAC to maintain its scientific 
advisory role and work with other federal agencies In developing a sound regula- 
tory framework to oversee these commercial applications. The formal regulatory 
bodies, such as FDA and EPA, will benefit from the expertise and experience of 
RAC and the foundation laid by the NIH Guidelines. The precipitous removal of 
RAC from any involvement with Industrial or agricultural applications would at 
this juncture be counterproductl ve. 
In summary, we urge RAC to continue its current role In scientific oversight of 
recombinant DNA research as that technology moves Into commercial application. 
This will provide a consistency and continuity that will facilitate commercial- 
ization and maintain the public confidence. 
RE: Federal Register notice for February 6 RAC meeting, 
49 FJR. 696 (January 5, 1984) 
Dear Dr. Gartland: 
Sincerely, 
■Judith A. Hautala, Ph.D. 
Chairman , 
IBC Committee 
Qenex Corporation • Science & Technology Center • 1 6020 Industrial Drive • Gaithersburg, Maryland 20877 
(301) 258-0552 • Telex 908775 
