Federal Register / Vol. 44, No. 232 / Friday, November 30, 1979 / Notices 
69215 
instructions and all other required 
procedures. 
11— B— 4— a— (12). Persons under 18 years 
of age shall not enter the P4 facility. 
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. 
II-B-4-a-(14). Street clothing shall be 
removed in the outer side of the 
clothing-change area and kept there. 
Complete laboratory clothing, including 
undergarments, head cover, 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 discard it 
into collection hampers before entering 
the shower area. 
ll-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. 
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 conducted. 
II— 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. 
U-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. 
U-B-4-b. Containment Equipment 
II— B — 4— b— (1). Experimental procedures 
involving organism that require P4-level 
physical containment shall be 
conducted either in (i) a Class 111 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— b— (2). Laboratory animals 
involved in experiments requiring P4- 
level physical containment shall be 
housed either in caged 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 areas in which all personnel 
are required to wear one-piece positive- 
pressure suits. 
II-B-4-b-{3). Alternative Selective 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 safequards are shown in 
Table II. 
Table II 
COMBINATIONS OF CONTAINMENT SAFEGUARDS 
Classification of 
experiment Alternate combinations of 
according to Guidelines physical and biological containment 
Physical Biological* * 
containment containment 
Physical containment 
Biological 
containment 
Laboratory Laboratory Containment 
design practices equipment 
specified for: specified for: specified for: 
P4 HV1 
P4 HV1 
P4 P4 P4 
P4 P4** P3 
HVl 
HV2 
* See Section II-D for description of biological containment. 
** In this case gloves shall be worn, in addition to the clothing requirements 
specified in II-B-4-a-( 14 ) . 
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 ultratviolet 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 
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