Page 8 - Revision of the Guidelines Subcommittee • lO/lS/90 
"Appendix K - FOOTNOTES. 
"1. The criteria in this grid address only the biological hazard associated with 
organisms containing recombinant DNA Other hazards accompanying the 
large scale cultivation of such organisms (e.g., toxic properties of products; 
physical, mechanical and chemical aspects of downstream processing) are not 
addressed and must be considered separately, albeit in conjunction with this 
grid. 
"2. Good Industrial Large Scale Practice as recommended by the Bioprocessing 
Committee of the Industrial Biotechnology Association and Pharmaceutical 
Manufacturers Association. 
"3. While not required, standard industry practice recommends restricted access 
at BL2-LS and higher. 
"4. Contingency measures for containing significant spillage from systems is 
recommended. 
"5. While not required, standard industry practice recommends that exhaust air 
from BL3-LS facilities be HEPA-filtered, subjected to thermal oxidation, or 
otherwise treated to prevent release of viable organisms. 
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