Letter to Gartland 
May 22, 1984 
Page 2 
level. Local oversight and decision-making authority is the most effective way 
to ensure a full examination of the organism, the procedures and the equipment 
followed by approval of a set of containment practices that appropriately re- 
flect both process realities and the requirements for worker safety and environ- 
mental protection. 
The approval by the RAC of these modifications to the large-scale containment 
Guidelines will be of benefit to the biotechnology industry and will help to 
maintain the U.S. competitive edge in this area. Adherence to the current 
Pl-LS containment conditions for processes using organisms covered under Appen- 
dix C could make some of these processes impractical. The proposed modifications 
will thus stimulate the industry while still providing adequate oversight and 
protection of human health and the environment. 
In summary, we strongly urge the approval of this Proposed Amendment by the 
RAC. 
Sincerely, 
-dudi t h A. Hautala, Ph.D. 
Director, Technology Assessment 
Chairman, IBC 
JAH/dh 
[ 679 ] 
