Page 8 of Attachment C 
Emergency and Accident Procedures 
Plans for emergencies, laboratory accidents, and safety precautions 
are being drafted by the company safety committee. 
CONCLUSIONS 
General experience has demonstrated that safe conduct of research or 
production processes involving hazardous entities is dependent on 
good work practices, availability and use of effective control tech- 
nology, and effective management. Microbiological Research requires 
containment features sufficient enough not only to exclude entry of 
contaminants into, but also prohibit escape of organisms from the 
system. Thus, attention to exposure control must receive equal em- 
phasis as process integrity and production development. Safety and 
health, medical surveillance, and emergency programs need to be im- 
plemented and managed with the same degree of attention that the 
scientific production programs receive. 
RECOMMENDATIONS 
Genentech needs to implement safety and health, medical surveillance 
and emergency programs and procedures immediately. These should be 
documented, understood by all concerned, and specific for Genentech' s 
operations. These programs should receive the same managerial atten- 
tion and administrative support as the production and scientific pro- 
grams. Emergency guidelines-, laboratory practices, personal hygiene 
habits and practices, protective clothing and equipment requirements, 
maintenance procedures, and medical surveillance are some specific 
areas where documented guidelines are needed. Such guidelines will 
serve only as well as they are responsibly implemented. Without ef- 
fective management and supervisory control these guidelines will only 
be ideals and not practices. 
A medical program should consist of preempioyment and annual 
physical 'examinations in order that employees may be monitored 
for abnormal health effects. Immunizations sh.ould be considered 
for employees working with known pathogens. Employees reporting 
to work from sick leave (after 3 or more days) should have the 
medical clearance of a physician. Employee records should be 
maintained and include notes on all illnesses, operations, phy- 
sical disorders, theraputic medications, and accidental expo- 
sures . 
A systematic scheduled preventive maintenance program for agi- 
tator seals, control valves, pressure relief valves and equip- 
ment/facility safeguards should be implemented. Sterilization 
of fermentor, feed lines, feed tanks, inoculating device, ex- 
haust port», sampling ports, and extraction devices must be 
validated by a procedure that demonstrates effective sterili- 
zation. 
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