17184 
Federal Register / Vol. 47. No. 77 / Wednesday, April 21. 1982 / Notices 
the P4 facility. Upon exit, personnel 
shall store this clothing in lockers 
provided for this purpose or discard it 
into collection hampers before entering 
the shower area. 
Il-B-4-a-{15). The universal 
biohazard sign is required on the P4 
facility access doors and on all interior 
doors to individual laboratory rooms 
where experiments are conducted. The 
sign shall also be posted on freezers, 
refrigerators, or other units used to store 
organisms containing recombinant DNA 
molecules. 
11-B 4 a -(16). An insect and rodent 
control program shall be instituted. 
U- B 4 a -^17). Aniipals and plants not 
related to the experiment shall not be 
permitted Th the laboratory in which the 
experiment is being conducted. 
U-B 4 q -{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. 
n-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. 
n-B-4-b. Containment Equipment. 
II-B-4-b-{l). Experimental procedures 
involving organisms that require P4- 
level physical containment shall be 
conducted either in (i) a Class III cabinet 
system or in (ii) Class I or Class U 
cabinets that are located in a specially 
designed area in which ail personnel are 
required to wear one-piece positive- 
pressure isolation suits. 
U-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-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 
I required to wear one-piece positive- 
I pressure suits. 
n-B-4-b-(3). Alternative Selection of 
I Containment Equipment 
Experimental procedures involving a 
host-vector system that provides a one- 
step higher level of biological 
containment than that specified can be 
conducted in the P4 facility using 
containment equipment requirements 
specified for the K level of physical 
II-B-4-C. Special Laboratory Design. 
U-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. 
Il-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 
airti^t.) 
Il-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 prorided, 
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 labortory or 
containment. Alternative combinations 
of containment safeguards are shown in 
Table II. 
animhi 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. 
ll-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 materials 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 activited by chemical treatment. 
HEPA niters shall be installed in all 
vents from effluent drains. 
II-B-4-c-(10). An individual supply 
and exhaust-air ventiliation system shall 
be provided. The system shall maintain 
pressure differentials and directional air 
flow as required to ensure inHow 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. 
Il-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 Altered 
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 
Table II— Combinations Of Containment Safeguards 
Oaradicabon o< axpanmem 
Animate combmahons of physicat and btologtcai containment 
Ptfytical 
Bioiogcal' 
contjyrvnent 
Pti)isical containment 
Laboralofy desgn 
tpaofiad lor— 
Laboratory practices 
speolied lor— 
Coniatnmeni 
eqiNpment spaohod 
tef- 
Biotogicat 
containmeni 
P4 
MV1 
P4, - 
P4,. 
P4 
HV1 
P4 
HV1 
P4 
P4>..» 
HV2 
3 „ . 
■ Sm MCton H-0 lof datcnpkon ol botoacN contaimwnl 
■ In tfw CAM glovw ihall b« nom. n adation Vo in* cVottNng foqtwwneow specified in ll-B-4-«-(14) 
[ 417 ] 
