Federal Register / Vol. 45, No. 227 / Friday, November 21, 1980 / Notices 
77389 
permitted in the laboratory in which the 
experiment is being conducted. 
11— B — 4— a— (18). Vacuum outlets shall be 
protected by filter and liquid 
disinfectant traps. 
II-B-4-a-(19). Use of the hypodermic 
needle and syringe shall be avoided 
when alternate methods are available. 
II-B-4-a-(20). The laboratory shall be 
kept neat and clean. 
II— B — 4— a— (21) If experiments involving 
other organisms which require lower 
levels of containment are to be 
conducted in the P4 facility concurrently 
with experiments requiring P4-level 
containment, they shall be conducted in 
accordance with all P4-level laboratory 
practices specified in this section. 
II— B — 1 4-b. Containment Equipment. 
II— B — 4— b— (1). Experimental procedures 
involvong organisms that require P4- 
leve! physical containment shall be 
conducted either in (i) a Class III cabinet 
system or in (ii) Class I or Class II 
cabinets that are located in a specially 
designed area in which all personnel are 
required to wear one-piece positive- 
pressure isolation suits. 
II-B-4-c. Special Laboratory Design. 
II— B — 4— c— (1). The laboratory shall be 
located in a restricted-access facility 
which is either a separate building or a 
clearly demarcated and isolated zone 
within a building. Clothing-change areas 
and shower rooms shall be provided for 
personnel entry and egress. These rooms 
shall be arranged so that personnel 
leave through the shower area to the 
change room. A double-door ventilated 
vestibule or ultraviolet air lock shall be 
provided for passage of materials, 
supplies, and equipment which are not 
brought into the P4 facility through the 
change room area. 
II-B-4-c-(2), Walls, floors, and 
ceilings of the F4 facility are constructed 
to form an internal shell which readily 
allows vapor-phase decontamination 
and is animal- and insect-proof. All 
penetrations through- these structures 
and surfaces ar sealed. (The integrity of 
the walls, floors, ceilings, and 
penetration seals should ensure 
II-B-4-b-(2). Laboratory animals 
involved in experiments requiring P4- 
level physical containment shall be 
housed either in cages contained in 
Class III cabinets or in partial 
containment caging systems (such as 
Horsfall units (19A], open cages placed 
in ventilated enclosures, or solid-wall 
and -bottom cages covered by filter 
bonnets, or solid-well and -bottom cages 
placed on holding racks equipped with 
ultraviolet irradiation lamps and 
reflectors) that are located in a specially 
designed area in which all personnel are 
required to wear one-piece positive- 
pressure suits. 
II— B — 4— b — (3). Alternative Selection of 
Containment Equipment. Experimental 
procedures involving a host-vector 
system that provides a one-step higher 
level of biological containment than that 
specified in Part III can be conducted in 
the P4 facility using containment 
equipment requirements specified for 
the P3 level of physical containment. 
Alternative combinations of 
containment safeguards are shown in 
Table II 
adequate containment of a vapor-phase 
decontaminant under static pressure 
conditions. This requirement does not 
imply that these surfaces must be 
airtight.) 
II-B-4-c-(3). A foot-, elbow-, or 
automatically-operated handwashing 
facility shall be provided near the door 
within each laboratory in which 
experiments involving recombinant 
DNA are conducted in openface 
biological safety cabinets. 
II— B — 4— c— (4). Central vacuum systems 
are permitted. The system, if provided, 
shall not serve areas outside the P4 
facility. The vacuum system shall 
include in-line HEPA filters near each 
use point or service cock. The filters 
shall be installed so as to permit in- 
place decontamination and replacement. 
Water supply, liquid and gaseous 
services provided to the P4 facility shall 
be protected by devices that prevent 
backflow.) 
II— B — 4 — c— (5). Drinking water fountains 
shall not be installed in laboratory or 
animal rooms of the P4 facility. Foot- 
operated water fountains are permitted 
in the corridors of the P4 facility. The 
water service provided to such fountains 
shall be protected from the water 
services to the laboratory areas of the 
P4 facility. 
II-B-4-c-(6). Laboratory doors shall 
be self-closing. 
II— B — 4— c— (7). A double-door autoclave 
shall be provided for sterilization of 
material passing out of the P4 facility. 
The autoclave doors shall be interlocked 
so that both doors will not be open at 
the same time. 
II-B-4-c-(8). A pass-through dunk 
tank or fumigation chamber shall be 
provided for removal from the P4 facility 
of material and equipment that cannot 
be heat-sterilized. 
II— B — 4— c— (9). All liquid effluents from 
the P4 facility shall be collected and 
decontaminated before disposal. Liquid 
effluents from biological safety cabinets 
and laboratory sinks shall be sterilized 
by heat. Liquid effluents from the 
shower and hand washing facilities may 
be activated by chemical treatment. 
HEPA filters shall be installed in all 
vents from effluent drains. 
II-B-4-c-(10). An individual supply 
and exhaust-air ventilation system shall 
be provided. The system shall maintain 
pressure differentials and directional air 
flow as required to ensure inflow from 
areas outside the facility toward areas 
of highest potential risk within the 
facility. The system shall be designed to 
prevent the reversal of air flow. The 
system shall sound an alarm in the 
event of system malfunction. 
II-B-4-c-(ll). Air within individual 
laboratories of the P4 facility may be 
recirculated if HEPA filtered. 
II-B-4-c-(12). The exhaust air from 
the P4 facility shall be HEPA filtered 
and discharged to the outdoors so that it 
is dispersed clear of occupied buildings 
and air intakes. The filter chambers 
shall be designed to allow in situ 
decontamination before removal and to 
facilitate certification testing after 
replacement. 
II-B-4-c-(13). The treated exhaust-air 
from Class I and Class II biological 
safety cabinets(20) may be discharged 
directly to the laboratory room 
environment or to the outdoors. The 
treated exhaust-air from Class III 
cabinets shall be discharged to the 
outdoors. If the treated exhaust-air from 
these cabinets is to be discharged to the 
outdoors through the P4 facility exhaust 
Table II .— Combinations of Containment Safeguards 
Alternate combinations of physical and biological containment 
Classification of experiment 
according to guidelines Physical containment 
Biological 
Physical 
Biological 1 
Laboratory 
Laboratory 
Containment 
containment 
containment 
containment 
design 
practices 
equipment 
specified for— 
specified for— 
specified for — 
P4 
HV1 
P4 
P4 
P4 
HV1 
P4 
HV1 
P4 
2 P4 
P3 
HV2 
1 See Section II— D for description of biological containment. 
2 In this case gloves shall be worn, in addition to the clothing requirements specified in ll-B-4-a-(14). 
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