Federal Register / Vol. 46, No. 233 / Friday, December 4, 1981 / Notices 
59373 
required to wear one-piece positive- 
pressure isolation suits. 
II-B-4-b-(2). Laboratory animals 
involved in experiments requiring P4- 
lev '. 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-wall 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 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. 
Table II.— Combinations of Containment 
Safeguards 
Classification of 
experiment 
Alternate combinations of physical and 
biological containment 
Physical 
contain- 
ment 
Biologi- 
cal ‘ 
contain- 
ment 
Physical containment 
Biologi- 
cal 
contain- 
ment 
Labo- 
ratory 
design 
speci- 
fied 
for — 
Labo- 
ratory 
prac- 
tices 
speci- 
fied 
for— 
Contain- 
ment 
equip- 
ment 
specified 
for — 
P4 
HV1 
P4 
P4 
P4. ., . 
HV1. 
HV2. 
P4„ 
HV1 
P4 
P4 2 
P3 
1 See Section ll-D for description of biological contain- 
ment. 
* In this case gloves shall be worn, in addition to the 
clothing requirements specified in ll-B-4-a-(14). 
II-B-4-C. Special Laboratory Design. 
II-B-4-c-(l). 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 P4 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 are sealed. (The integrity 
of the walls, floors, ceilings, and 
penetration seals should ensure 
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. 
Il-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 
w'ater 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-^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 carmot 
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 rev’ersal 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 in HEPA filtered. 
lI-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-^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 
air system, it shall be connected to this 
system so as to avoid any interference 
with the air balance of the cabinets or 
the facility exhaust air system. 
II-B-4-c-(14). As noted in Section II- 
B-4-b-(l), the P4 facility may contain 
specially designed areas in which all 
personnel are required to wear one- 
piece positive-pressure isolation suits. 
Such areas shall be airtight. The 
exhaust-air from the suit area shall be 
filtered by two sets of HEPA filters 
installed in series, and a duplicate 
filtration unit and exhaust fan shall be 
provided. The air pressure within the 
suit area shall be less than that in any 
adjacent area. An emergency lighting 
system, communication systems, and 
power source shall be provided. A 
double-door autoclave shall be provided 
for sterilization of all waste materials to 4 
be removed from the suit area. 
Persormel who enter this area shall 
wear a one-piece positive-pressure suit 
that is ventilated by a life-support 
system. The life-support system shall be 
provided with alarms and emergency 
backup air. Entry to this area is through 
an airlock fitted with airtight doors. A 
chemical shower area shall be provided 
to docontaminate the surfaces of the suit 
before removal. 
II-C. Shipment. Recombinant DNA 
molecules contained in an organism or 
virus should be shipped only as an 
etiologic agent under requirements of 
the U.S. Public Health Service, and the 
U.S. Department of Transportation 
(§ 72.3, Part 72, Title 42, and §§ 173.38&- 
173.388, Part 173, Title 49, U.S. Code of 
Federal Regulations (CFR)) as specified 
below: 
lI-C-1. Recombinant DNA molecules 
contained in an organism or virus 
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