Federal Register / Vol. 46. No. 126 / Wednesday, July 1. 1981 / Notices 
34467 
Complete laboratory clothing, including 
undergarments, head covers, shoes, and 
either pants and shirts or jumpsuits, 
shall be used by all persons who enter 
the P4 facility. Upon exit, personnel 
shall store this clothing in lockers 
provided for this purpose or discared it 
into collection hampers before entering 
the shower area. 
U-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 exf>eriments are conducted. The 
sign shall also be posted on freezers, 
refrigerators, or other units used to store 
organisms containing recombinant DNA 
molecules. 
Il-B-4-a-(16). An insect and rodent 
control program shall be instituted. 
U-B-4-a-(17]. Animals and plants not 
related to the experiment shall not be 
permitted in the laboratory in which the 
experiment is being conducted. 
U-B-4-a-(18). Vacuum outlet shall be 
protected by filter and liquid 
disinfectant traps. 
U-B-4-a-{19). Use of the hypodermic 
needle and syringe shall be avoided 
when alternate methods are available. 
Il-B-4-a-(20). The laboratory shall be 
kept neat and clean. 
Il-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 speciHed in this section. 
n-B-4-b. Containment Equipment 
Il-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 II 
cabinets that are located in a specially 
designed area in which all personnel are 
required to wear one-piece positive- 
pressure isolation suits. 
ll-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 (79/4), 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. 
lI-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 111 can be conducted in 
the P4 facility using containment 
equipment requirements spedfled for 
I1-B-4-C. Special Laboratory Design. 
Il-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-<-{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 suHaces must be 
airtight.) 
lI-B-4-<-(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. 
lI-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 
the P3 level of physical containment. 
Alternative combinations of 
containment safeguards are shown in 
Table 11. 
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-(0). 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. 
n-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 Alters shall be installed in all 
vents from effluent drains. 
Il-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. 
Il-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 Alter chambers 
shall be designed to allow in situ 
Table \\.^-Combinatlons of Containment Safeguards 
C>as«fic«i)on ol opannxnt accontnQ to 
gmd«*oei 
conSilnations ol p^yslcal and t»ok)gKal conlammeni 
Pnysical contamment 
contammaX 
Btoto^ce 
ooniaaonani ' 
Laboralory daaign 
apacrflad lof 
Laboratory 
practicas apaol«d 
lor 
Contawneot 
aqupmenl 
speoiied lor 
Biological 
containment 
Pa 
P4.._ 
HVI. 
MV1. 
pa- 
pa. 
Pa'- 
pa 
P3 
HVI. 
HV2. 
' Saa Sacton S-0 tor da s c o pltott ol b«toglcal contatomanl 
■ In Saa caaa gtoaaa eiat ba worn, ai adoaon lo tia ctodttog raquramanit speciiiad m ll-e-a-a-(ia). 
[ 155 ] 
