Federal Register / Vol. 47, No. 102 / Wednesday, May 26. 1982 / Notices 
23131 
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. 
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-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 from the P4 facility of 
material and equipment that cannot be heat- 
sterilized. 
Appendix G-Il-D-3-i. 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 filters shall be 
installed in all vents from effluent drains. 
Appendix G-Il-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 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-II-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 through 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-U-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 fltted with airtight 
doors. A chemical shower area shall be 
provided to decontaminate the surfaces of the 
suit before removal. 
Appendix G-IIL 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. Classiflcation of Etiologic 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. (NEH) 75-790. 
4. National Institutes of Health Biohazards 
Safety Guide (1974). U.S. Department of 
Health, Education, and Welfare, Public 
Health Service, National 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 ]. 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. Acade’mic 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. ). Bact. 40, 569-580. 
12. Biological safety cabinets referred to in 
this section are classified as Class /, Class II, 
or Class III cabinets. A Class 7 is a ventilated 
cabinet for pessonnel 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 open 
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, llie face velocity of the 
inward flow of air through the full-width open 
front is 75 feet per minute or greater. 
A Class //cabinet is a ventilated cabinet 
for personnel and product protection having 
an open front with inward air flow for 
personnel protection, and HEPA filtered mass 
recirculated air flow for product protection. 
The cabinet exhaust air is Altered through a 
HEPA filter. The face velocity of the inward 
flow of air through the full-width open front it 
75 feet per minute or greater. Desi^ and 
performance specificaAons for Class II 
cabinets have been adopted by the National 
Sanitation Foundation, Ann Arbor, Michigan. 
A Class III cabinet is a closed-front 
ventilated cabinet of gas-tight construction 
which provides the highest level of personnel 
protection of all biohazard safety cabinets. 
The interior of the cabinet is protected from 
contaminants exterior to the cabinet The 
cabinet is Atted With arm-length rubber 
gloves and is operated under a negative 
pressure of at least 0.5 inches water guage. 
All supply air is Altered through HEPA Biters. 
Exhaust air is Altered through two HEPA 
filters or one HEPA Alters. Exhaust air is 
filtered through two HEAP Alters or one 
HEPA Alter and incinerator before being 
discharged to the outside environment. 
Appendix H — Shipment 
Recombinant DNA molecules contained in 
an organixm or virus shall be shipped only as 
an etiologic agent under requirements of tiie 
U.S. Public Health Service, and the U.S, 
Department of Transportation (Section 72.3, 
Part 72, Title 42, and Sections 173.388-.388, 
Part 173, Title 49, U.S. Code of the Federal 
Regulations (CFR)) as speciAed below: 
Appehdix H-I. Recombinant DNA 
molecules contained in an organism or virus 
requiring Pi, P2, or P3 physical containment, 
when offered for transportation or 
transported, are subject to all requirements of 
Section 782.3(a)-(e), Part 72, Title 42 CFR, and 
Sections 173.386-.388, Part 173, Title 49 CFR, 
Appendix H-U. Recombinant DNA 
molecules contained in an organism or virus 
requiring P4, physical containment, when 
offered for transportation or transported, are 
subject to all requirements listed above under 
Appendix H-I and are also subject to Section 
72.3(f), Part 72, Titl^ CFR. 
Appendix H-III. Additional information on 
packaging and shipment is given in the 
“Laboratory Safety Monograph — A. 
Supplement to the NIH Guidelines for 
Recombinant DNA Research,” available from 
ORDA. 
[Note. — ^Instructions for the packaging and 
labeling of etiologic agents will be printed in 
the revised Guidelines should that proposal 
be accepted by the RAC.] 
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