MJiMUKAIN D U iVl 
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PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES Or HEALTH 
to : Gilbert Omenn, M.D./Ph.D. date: March 12, 1980 
Associate Director for Human Resources 
and Social and Economic Services 
Office of Science and Technology Policy 
from : Director, NIH 
subject: industrial Practices Subcommittee of the Federal Interagency Advisory 
Committee on Recombinant DNA Research 
At its meeting on February 27, the Federal Interagency Advisory Committee 
on Recombinant DNA Research approved creation of an Industrial Practices 
Subcommittee. With the Committee's approval, I asked you to serve as 
Chairman; I am now writing to confirm this request. 
I believe it important to review the considerations that led to the develop- 
ment of this Subcommittee and to its mandate. As reported at the meeting, 
several important scientific developments in recombinant DNA research over 
the past year involve industrial applications; among these are the production 
of insulin, growth hormone, and most recently interferon. These developments 
have directed new attention to the role of the industrial sector in recombinant 
DNA technology — an area in which NIH Guidelines apply only on a voluntary 
basis. It was against this background that Dr. Eula Bingham, Assistant 
Secretary for Occupational Safety and Health, Department of Labor, wrote to 
me in December 1979 expressing her concern about potential hazards to workers 
exposed to recombinant DNA technology. I suggested in response that this 
matter be brought before the Federal Interagency Advisory Committee; hence, 
our February 27 meeting. 
The Committee discussed the issue of occupational health and Federal responsi- 
bilities attendant upon industrial applications of recombinant DNA technology. 
On the basis of that discussion it was agreed that a Subcommittee should be 
created to provide appropriate guidance for the full Committee on what steps 
need be taken, if any, beyond the NIH guidelines relating to industrial uses 
of recombinant DNA technology. It was felt that such a Subcommittee should 
meet at the earliest opportunity. 
In considering issues of occupational health and other Federal responsibilities 
attendant upon industrial applications of recombinant DNA technology, the 
Subcommittee has the following responsibilities: 
• To consider consents directed to member agencies concerning these 
issues ; 
• To provide a point of contact on these issues for persons outside 
the Federal Government and, where appropriate, to seek their advice, 
consultation, and participation in the work of the Subcommittee; 
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