33074 
NOTICES 
II-B-4-a-(lI). ‘Only persons whose 
entry into the P4 facility is required to 
meet program or support needs shall 
be authorized to enter. Before enter- 
ing. such persons shall be advised of 
the nature of the research being con- 
ducted and shall be Instructed as to 
the appropriate safeguards to Insure 
their safety. They shall comply with 
instructions and all other required 
procedures. 
II-B-4-a-< 12). ‘Persons under 18 
years of age shall not enter the P4 fa- 
cility. 
II-B-4-a-<13>. ‘Personnel shall enter 
into and exit from the P4 facility only 
through the clothing change and 
shower rooms. Personnel shall shower 
at each egress from the P4 facility. Air 
locks shall not be used for personnel 
entry or exit except for emergencies. 
Il-B-4-a-< 14). ‘Street clothing shall 
be removed In the outer side of the P4 
facility clothing change area and kept 
there. Complete laboratory clothing 
including undergarments, head cover, 
shoes, and either pants and shirts or 
Jumpsuits shall be provided and used 
by all persons who enter the P4 facili- 
ty. Upon exit, personnel shall store 
this clothing in lockers provided for 
this purpose or discard it into collec- 
tion hampers before entering the 
shower area. 
II-B-4-a-( 15). ‘The universal bioha- 
zard sign is required on the P4 facility 
access doors and all interior doors to 
individual laboratory rooms where ex- 
periments are conducted. 
II-B-4-a-( 16). An insect and rodent 
control program shall be instituted. 
II-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 con- 
ducted. 
II-B-4-a-( 18). Use of the hypoder- 
mic needle and syringe shall be avoid- 
ed when alternate methods are availa- 
ble. 
Table tl 
II-B-4-C. Special Laboratory Design. 
II-B-4-c-<l). ‘The laboratory shall 
II-B-4-a-<19). The laboratory shall 
be kept neat and clean. 
II-B-4-a-( 20). ‘If experiments In- 
volving other organisms which require 
lower levels of containment are to be 
conducted in the P4 facility concur- 
rently with experiments requiring P4- 
level containment, they shall be con- 
ducted in accordance with all P4-level 
laboratory practices specified in this 
section. 
II-B-4-b. Containment Equipment 
II-B-4-b-<l). ‘Experimental proce- 
dures involving organisms which re- 
quire P4-level physical containment 
shall be conducted either in <l) a class 
III cabinet system or in (11) class I or 
class II cabinets that are located In a 
specially designed area In which all 
personnel arc required to wear one- 
piece positive- pressure Isolation suits. 
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 contain- 
ment caging systems (such as Horsfall 
units, 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 ultravio- 
let irradiation lamps and reflectors) 
that are located in a specially designed 
area in which all personnel are re- 
quired to wear one-piece positive-pres- 
sure suits. 
II-B-4-b-(3). ‘ Alternative Selection 
of Containment Equipment Experi- 
mental procedures Involving a host- 
vector system which provides a one- 
step higher level of biological contain- 
ment than that specified In Part III 
can be conducted in the P4 facility 
using containment equipment require- 
ments specified for the P3 level of 
physical containment. Alternative 
combinations of containment safe- 
guards are shown In table II. 
be located in a restricted access facili- 
ty 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 egress is through 
the shower area to the change room. A 
double-door ventilated vestibule or ul- 
traviolet 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 ceil- 
ings 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 pene- 
tration seals should insure adequate 
containment of a vapor-phase deconta- 
minant under static pressure condi- 
tions. This requirement does not imply 
that these surfaces must be airtight.) 
II-B-4-c-<3). ‘A foot-, elbow-, or 
automatically-operated hand washing 
facility shall be provided near the door 
within each laboratory in which ex- 
periments Involving recombinant DNA 
are conducted in open-face biological 
safety cabinets. 
II-B-4-c-<4). ‘Where a central 
vacuum system is provided, it shall not 
serve areas outside the P4 facility. The 
vacuum system shall include in-line 
HEPA filters as near as practicable to 
each use point or service cock. The fil- 
ters shall be installed so as to permit 
in-place decontamination and replace- 
ment. Water supply and liquid and 
gaseous services provided to the P4 fa- 
cility shall be protected by devices 
that prevent backflow. 
II-B-4-c-(5). ‘Foot-operated water 
fountains are permitted in the corri- 
dors of the P4 facility. The water serv- 
ice provided to the fountain 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 auto- 
clave shall be provided for sterilization 
of material passing out of the P4 fa- 
cility. The autoclave doors shall be in- 
terlocked so that both doors will not 
be open at the same time. 
II-B-4-c-<8). ‘A passthrough dunk 
tank or fumigation chamber shall be 
provided for removal of material and 
equipment that cannot be heat-steril- 
ized from the P4 facility. 
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 
ockbiwvticns of aa/ovrwic saftglapcs 
Classification of 
tipnnnt 
•coord inq to Guidelines 
Alternate combinations of Oivsical and biological contairrent 
Physical Biological* 
containment conta inner: t 
Phystcal conta inrent 
Biological 
contairrent 
Laboratory Laboratory Contaimer.t 
desiipi practices equipment 
specified for: specified for: specified for: 
P4 HV1 
P4 HV1 
P4 P4 P4 
N M P3 
HV1 
HV2 
* See Section II-O for description of biological aor.taiment. 
FEDERAL REGISTER. VOL 43. NO. 146— FRIDAY, JULY 28, 1978 
[ 35 ] 
