Federa. Register / Vol. 48, No. 106 / Wednesday, June 1, 1983 / Notices 
24573 
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. 
Appendix G-II-D-3-b. Walls, floors, 
and ceijings 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 contaiment of a vapor- 
phase decontiminant under 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 
installed so as to permit in-place 
decontamination and replaceement. 
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 
fountains 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 fountains 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-Il-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-lI-D-3-h. 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. 
Appendix G — 1 1 — D— 3— i . All liquiid 
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 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 
endure 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. 
Appendix G-II-D-3-k. Air within 
individual laboratories of the P4 facility 
may be recirculated if HEPA filtered. 
Appendix G-ll-D-3-1. 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 filter 
chambers shall be designed to allow in 
situ decontamination before removal 
and to facilitate certification testing 
after replacement. 
Appendix G-II-D-3-m. The treated 
exhaust-air from Class I and Class II 
biological safety cabinets [12] may be 
discharged directly to the laboratory 
room environment or to the outdoors. 
The treated exhaust-air from Class III 
cabinets shall be discharged to the 
outdoors. If the treated exhaust-air from 
these cabinets is to be discharged to the 
outdoors thourgh the P4 facility exhaust 
air system, it shall be connected to this 
system so as to avoid any interference 
with the air balance of the cabinets or 
the facility exhaust air system. 
Appendix G-II-D-3-n. As noted in 
Appendix G-II-D-2-a, the P4 facility 
may contain specially designed areas in 
which all personnel are required to wear 
one-piece positive-pressure isolation 
suits. Such areas shall be airtight. The 
exhaust-air from the suit area shall be 
filtered by two sets of HEPA filters 
installed in series, and a duplicate 
filtration unit and exhaust fan shall be 
provided. The air pressure within the 
suit area shall be less than that on any 
adjacent area. An emergency lighting 
system, communication systems and 
power source shall be provided. A 
double-door autoclave shall be provided 
for sterilization of all waste materials to 
be removed from the suit area. 
Personnel who enter this area shall 
wear a one-piece positive-pressure suit 
that is ventilated by a life-support 
system. The life-support system shall be 
provided with alarms and emergency 
backup air. Entry to this area is through 
an airlock fitted with airtight doors. A 
chemical shower area shall be provide 
to decontaminate the surfaces of the suit 
before removal. 
Appendix G— III. Footnotes and 
References of Appendix G. 
1. Laboratory Safety at the Center for 
Disease Control (Sept. 1974). U.S. Department 
of Health, Education and Welfare Publication 
No. CDC 75-8118. 
2. Classification of Elio logic Agents on the 
Basis of Hazard. (4th Edition, July 1974). U.S. 
Department of Health, Education and 
Welfare. Public Health Service. Centers for 
Disease Control. Office of Biosafety, Atlanta, 
Georgia 30333. 
3. National Cancer Institute Safety 
Standards for Research Involving Oncogenic 
Viruses (Oct. 1974). U.S. Department of 
Health, Education and Welfare Publication 
No. (NIH) 75-790. 
4. National Institutes of Health Biohazards 
Safety Guide (1974). U.S. Department of 
Health, Education, and Welfare, Public 
Health Service, Natonal Institutes of Health. 
U.S. Government Printing Office, Stock No. 
1740-00383. 
5. Biohazards in Biological Research 
(1973). A. Heilman, M. N. Oxman, and R. 
Pollack (ed.) Cold Spring Harbor Laboratory. 
6 . Handbook of Laboratory Safety (1971). 
Second Edition. N. V. Steere (ed.). The 
Chemical Rubber Co., Cleveland. 
7. Bodily, J. L. (1970). General 
Administration of the Laboratory, H. L 
Bodily, E. L. Updyke, and J. O. Mason (eds.). 
Diagnostic Procedures for Bacterial, Mycotic 
and Parasitic Infections. American Public 
Health Association, New York, pp. 11-28. 
8. Darlow, H. M. (1969). Safety in the 
Microbiological Laboratory. In J. R. Norris 
and D. W. Robbins (ed.). Methods in 
Microbiology. Academic Press. Inc. New 
York. pp. 169-204. 
9. The Prevention of Laboratory Acquired 
Infection (1974). C. H. Collins. E. G. Hartley, 
and R. Pilsworth. Public Health Laboratory 
Service, Monograph Series No. 6 . 
10. Chatigny, M. A. (1961). Protection 
Against Infection in the Microbiological 
Laboratory: Devices and Procedures. In W. 
W. Umbreit (ed.). Advances in Applied 
Microbiology. Academic Press, New York, 
N.Y. 3:131-192. 
11. Horsfall, F. L., Jr., and J. H. Baner (1940). 
Individual Isolation of Infected Animals in a 
Single Room. J. Bact. 40, 569-580. 
12. Biological safety cabinets referred to in 
this section are classified as Class I, Class // 
or Class III cabinets. A Class l is a ventilated 
cabinet for personnel protection having an 
inward flow of air away from the operator. 
The exhaust air from this cabinet is filtered 
through a high-efficiency particulate air 
(HEPA) filter. This cabinet is used in three 
operational modes: (1) With a full-width ope 
front, (2) with an installed front closure panel 
(having four 8-inch diameter openings) 
without gloves, and (3) with an installed front 
closure panel equipped with arm-length 
rubber gloves. The face velocity of the 
inward flow of air through the full-width open 
front is 75 feet per minute or greater. 
A Class II cabinet is a ventilated cabinet 
for personnel and product protection having 
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