Physical containment facilities will continue to be designed and 
operated based on the biological containment features of the production 
organism. In addition, containment practices and other environmental 
and occupational health issues relevant to pharmaceutical manufacturing 
are thoroughly assessed by FDA as part of their regulatory 
responsibility. 
We hope these comments are helpful as NIH-RAC considers the proposed 
changes, and we are pleased to see the continuing review of the 
guidelines based on the growing experience with recombinant DNA 
technology. 
Sincerely , 
CAROL LAX HOERNER, Ph.D. 
Manager, Environmental Health 
Biosafety Officer 
CLH : smd 
4/48 
Recombinant DNA Research, Volume 1 1 l 277 l 
