Attachment IV - Page 4 
3. 
o Although the potential for a catastrophic failure of one of these 
fermenters is extremely small, each facility has been designed to 
totally contain the contents of the largest fermenter. Should this 
ever occur, the entire fermenter's contents will be collected in a 
dike or drained to a collection tank. The culture will be 
inactivated prior to disposal. Although the NIH Guidelines at the 
Pl-LS level of containment require that the containment be designed 
only to minimize release of recombinant organisms many of the steps 
described above are designed to prevent the release or escape of 
viable organisms during normal operating conditions. 
2. Operating Practices 
In addition, operating practices have been established at each facility 
to ensure containment. These include: 
o Compliance with PI laboratory practices for working with recombinant 
organi sms . 
o Autoclaving of all waste materials and equipment related to 
laboratory operations, inoculation or sampling. 
o A preventative maintenance program to inspect, clean and lubricate 
facility equipment and ensure proper operation. 
o Limited access to the facilities at all times. 
o Training of all laboratory staff and production operators. 
o Establishment of emergency response plans for dealing with potential 
emergencies, e.g. spills and equipment failures. 
o A health surveillance program for all laboratory and production 
personnel working with recombinant organisms. 
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