38064 
Federal Re^ster / Vol. 47, No. 167 / Friday, August 27, 1982 / Notices 
Appendix G-II-4)-l-^. Street clothing 
shall be removed in the outer side o£ 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. 
Appendix G-D-D-l-o. 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 oUier units used to store 
organisms containing recombinant DNA 
molecules. 
Appendix G-D-D-l-p. An insect and 
rodent control program shall be 
instituted. 
Appendix G-II-D-l-q. Animals and 
plants not related to the experiment 
shall not be permitted in the laboratory 
in which the experiment is being 
conducted. 
Appendix G-Il-4}-lHr. Vacuum outlets 
shall be protected by filter and liquid 
disinfectant traps. 
Appendix G-II-D-l-s. Use of the 
hypodermic needle and syringe shall be 
avoided when alternate methods are 
available. 
Appendix G-D-D-l-t. The laboratory 
shall be kept neat and clean. 
Appendix G-II-I>-l-u. If experiments 
involving other organisms which require 
lower levels of containment are to be 
conducted in the P4 facility concurrently 
with experiments requiring P4-Ievel 
containment they shall be conducted in 
accordance with all P4-level laboratory 
practices specified in this section. 
Appendix G-II-D-2. Containment 
Equipment. 
Appendix G-II-D-2-a. Experimental 
procedures involving organisms that 
require P-level physical containment 
shall be conducted either in (i) a Class 
in cabinet system or in (ii) Class I or 
Class n cabinets that are located in a 
specially designed area in which all 
personnel are required to wear one- 
piece positive-pressure isolation suits. 
Appendix G-II-D-2-b. Laboratory 
animals involved in experiments 
requiring P4-level physical containment 
shall be housed either in cages 
contained in Class ID cabinets or in 
partial containment caging systems 
(such as Horsfall units [11], 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. 
Appendix G-II-D-2-c. Alternative 
Selection of Containment Equipment. 
Experimental procedures involving a 
host-vector system that provides a one- 
Appendix G-II-D-3. Special 
Laboratory Design. 
Appendix G-II-D-3-a. 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 
throu^ 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. 
Appendix G-II-D-3-b. 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 imder static 
pressure conditions. This requirement 
does not imply that these surfaces must 
be airtight.) 
Appendix G-II-D-3-c. 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. 
Appendix G-II-D-3-d. 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 
step higher level of biological 
containment than that specified 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 U. 
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. 
Appendix G-II-D-3-e. Drinking water 
foimtains 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 water service provided to 
such foimtains shall be protected from 
the water services to the laboratory 
areas of the P4 facility. 
Appendix G-II-D-3-f. Laboratory 
doors shall be self-closing. 
Appendix G-II-D-3-g. 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. 
Appendix G-II-D-3-h. A pass-through 
dunk tank or fumigation chamber shall 
be provided for removal fi'om the P4 
facility of material and equipment that 
cannot be heat-sterilized. 
Appendix G-II-D-3-i. All liquid 
effluents fi'om 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 activitated by 
chemical treatment HEPA filters shall 
be installed in all vents from effluent 
drains. 
Appendix G-II-D-3-j. 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 firom areas outside the 
facility toward areas of highest potential 
Table II.— Possible Combinations of Containment Safeguards 
Classification of experiment 
Altamativa combinations of physical and biological 
containment 
Biological 
contalnmsnt 
Physical containment 
Biological ' 
containment 
Physical containment 
Laboratory design 
specified for— 
Ijboratofy 
practtcM 9p6cttlod 
lor— 
Contoinfoont 
ipodfiod lor— 
P4 
HV1 
P4 
PA 
PA 
HV1. 
HVi 
P4 
HV1 
P4 
P4 * 
P3 
‘See Appendix I for description of blologicel corrtainment 
’In this case gloves Shan be worn, in addttion to ttie clothing roquiramants ^tecHled In Appendix Q-ll-O-l-n. 
[18] 
