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3. Cost Impact 
The direct cost impact of the NIH Guidelines is the cost of complying 
with their provisions. The costs will vary according to the level of 
potential risk of the research. There are no special facility require- 
ments for wonk with minimal- and low-risk recombinant DNA materials 
(Pi and P2 containment). There are equipment requirements for work 
involving low-risk recombinant DNA materials that will involve little 
cost impact. Low-risk research requires a biological safety cabinet 
for procedures that may produce significant aerosols and an autoclave 
for sterilizing waste materials. These items of equipment, however, 
are generally available within the existing facilities where such research 
is being conducted. The cost impact of the NIH guidelines on minimal - 
and low-risk research is therefore not significant. 
Special equipment and facility requirements are specified for 
moderate -risk recombinant DNA research (P3). All work at this 
level of potential risk is to be conducted within class I or II biological 
safety cabinets. This requirement will necessitate the acquisition of 
many additional cabinets, depending on the scope of the research effort. 
It is estimated that one cabinet, costing approximately $5, 000, will 
be required for every three persons involved in the research. 
Directional air flow, single -pass ventilation, and provisions for 
ensuring restricted access are specified requirements for moderate 
risk (P3) recombinant DNA research. While many new facilities (those 
constructed in the last decade) have this capability, few older facilities 
can provide it without extensive renovation. Creating adequate access 
control by construction of architectural barriers (air locks, double - 
door alcove, etc.) is not expensive. However, the cost of renovating 
air-handling systems to provide for single -pass, directional air flow 
may prevent some institutions from conducting moderate -risk research. 
It has been estimated that installation of air-handling systems that comply 
with the NIH Guidelines would cost approximately $200 per square foot 
of space serviced by the system. 
The NIH Guidelines require that high-risk (P4) research involving 
recombinant DNA materials be conducted only in class III biological 
safety cabinets (glove boxes) that are installed in maximum -security 
facilities. Fewer than 30 facilities within the United States have the 
potential for meeting the requirements. A smaller number may actually 
be available for this research. The cost of constructing and equipping 
a maximum -security facility having two 10-foot by 20-foot laboratory 
modules with class III cabinetry is estimated at $750, 000. This high 
cost is due to sophisticated mechanical support systems (e.g., negative 
pressure, exhaust air filtration, air-waste treatment plant), and 
architectural barriers (e.g., clothes -change rooms, airlocks, waste- 
staging areas, and monolithic walls, floors, and ceilings). The cost 
of class III cabinetry installed is approximately $3, 000 per linear foot. 
In addition, the cabinetry line and the facility each require a double -door 
autoclave, costing a minimum of $15, 000 and $65, 000 respectively. 
