Page 5 of Attachment D 
EVALUATION OF THE PLANT AND PROCURE 
Physical Containment Design 
Several P-2 and P-1 containment level laboratories and a very well designed 
P-3 laboratory were inspected. The design and operation of these Labora- 
tories were well within the NIH guidelines. Berkeley and Emeryville each 
have municipal ordinances that require biological, genetic, and molecular 
biological research be conducted within guidelines similar to, and in 
some regards more stringent than, the NIH requirements. In essence, by 
complying with the Berkeley and Emeryville ordinances, Cetus is operating 
within the NIH guidelines. 
Engineering Controls 
The ventilation systems, exhaust gas filtration, waste products control, 
biological safety cabinets, access barriers, and all interior room sur- 
faces in the P-3 and P-2 laboratories were within the NIH guidelines. All 
'laboratories were well planned, constructed, and utilized. With minor 
equipment changes, the P-3 level laboratory could be used as a P-4 laboratory. 
All liquid wastes from the P-3 laboratory are treated in a bio-waste sys- 
tem located on the plant site. 
An automated security computer system monitors the ventilation systems, 
access areas, safety cabinets, centrifuges, autoclaves, and ambient envi- 
ronment of the laboratories. The performance of this system is checked 
periodically by the company which installed it. 
Validation Procedures 
All biological safety cabinets and walk in hoods xeceive scheduled perfor- 
mance testing and certification. Autoclaves are monitored by integral 
recording charts to document performance. 
All centrifuge equipment receives periodic maintenance checks. Vali- 
dation, of active sterilisation is conducted on systems required under the 
KIH guidelines. 
'All of the above mentioned procedures are in addition to the continuous 
monitoring by the security computer system. 
VoTk Practices 
Specific guidelines for safe work practices and laboratory techniques have 
been promul gazed by the Environmental Health and Safety Manager and the 
Company safety comittee. Employee observance of these guidelines seemed 
Very good.* There was no evidence of drinking, eating or smoking in -ne 
laboratories and all the workers were wearing the appropriate protective 
Clothing. 
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