Page 10 of Attachment C 
The Pl-LS production area should be segregated from ocher production 
or research operations. This would maintain the integrity of the pro- 
cess and procedures ouclined for recombinant DNA fermentacion pro- 
cesses. Such system isolation will also enhance the containment of 
the entire operation to preclude accidental exposure to, and from, 
other employees and processes. 
Specific procedures whould be employed for handling chemical and 
radiological wastes. Only personnel trained in these procedures 
should handle the wastes. Protective clothing should be decontamin- 
ated, or marked hazardous so the laundry may handle these garments 
appropriately. 
The use of formaldehyde as a disinfecting agent in laboratory areas 
merits certain precautions. Employees should wear rubber gloves when 
working with formaldehyde and when contact with the hands is likely. 
If the disinfection process involves occasional brief exposures to 
formaldehyde at concentrations in excess of 1.2 mg/cubic meter an 
appropriate respirator should be used. A respirator training program 
would then also be required, with emphasis on cleaning, maintenance, 
and proper fit. A step by step procedure should be outlined and only 
personnel trained in the disinfection procedure and the respirator 
program would be allowed to use formaldehyde. Access to the area 
during the disinfection procedure should be restricted. Detector tubes 
should be used to determine when it is safe to enter the disinfected 
area. These tubes can also be used to assure that formaldehyde fumes 
are not escaping to other laboratories, offices, or public areas. 
Maintenance of the fermentation systems, or in the laboratories, 
should take place only after lock out procedures have been imple- 
mented, a verification of clean systems has been made, and clearance 
from the operator and a supervisor has been obtained. 
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