Federal Register / Vol. 47. No. 167 / Friday. August 27. 1982 / Notices 
38065 
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 C-lI-D-3-k. Air within 
individual laboratories of the P4 facility 
may recirculated if HEPA filtered. 
Appendix C-lI-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 
$itu decontamination before removal 
and to facilitate certification testing 
after replacement. 
Appendix G-(l-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 envirorunent 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 connect^ to this 
system so as to avoid any interference 
with the air balance of the cabinets or 
the facility exhaust air system. 
Appendix C-Il-D-3-n. As noted In 
Appendix C-II-I>-2-a. the P4 facility 
may contain specially designed areas in 
which all persormel 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 
nitration 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-suppoii 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 provided 
to decontaminate the surfaces of the suit 
before removal. 
Appendix C-IH. Footnotes and References of 
Appendix G 
1. Laboratory Safety at the Center for 
Disease Control (Sept. 1974). U.S. Department 
at Health Education and Welfare Publication 
No. CDC 75-8118. 
2. Classification 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 at 
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. 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. 
8 Handbook of Laboratory Safety (1971). 
Second Edition. N. V. Steere (ed.) The 
Chemical Rubber Co.. Cleveland. 
7. Bodily. |. L (1070). 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 Dariow. H. M. (1080). Safety in the 
Microbiological Laboratory. In |. R. Norris 
and D. W. Robbins (ed.). Method in 
Microbiology. Academic Press. Inc. New 
York. pp. 180-204. 
0. The Prevention of Laboratory Acquired 
Infection (1974). C H. Collins. E G. Hartley, 
and R. Pilsworth. Public Health Laboratory 
Service. Monograph Series No. 8 
18 Chatigny. M. A (1001). 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. 3:131-102. 
11. Horsfall. F L. jr.. and |. H. Baner (1940). 
Individual Isolation of Infected Animals in a 
Single Room. |. Beet 40. 500-580. 
12. Biological safety cabinets referred to In 
this section are classified as Class 1. Class ll. 
or Class III cabinets. A Class / 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) Biter. This cabinet is used in three 
operaUonal modes: (1) with a full-width open 
front (2) with an Installed front closure panel 
(having four 8inch diameter openings) 
without gloves, and (3) with an installed front 
closure panel equipped witli arm-length 
rubber gloves. Ibe face velocity of the 
Inward flow of air through the full-width open 
front is 75 feel per mipule or greater. 
A Class ll cabinet is a ventilated cabinet 
for personnel and product protection having 
an open front with inward air flow for 
personnel protection, and HEPA Tillered mass 
recirculated air flow for product protection. 
The cabinet exhaust air is filtered through a 
HEPA filter. The face velocity of the inward 
flow of air through the full-width open front ia 
75 feet per minute or greater. Design and 
performance specifications for Class I! 
cabinets have been adopted by the National 
Sanitation Foundation. Ann Arbor. Michigan. 
A Class III cabinet is a closed-front 
ventilated cabinet of gas-light construction 
which provides the highest lev*el of personnel 
protection of all biohazard safely cabinets. 
The interior of the cabinet is protected from 
contaminants exterior to the cabinet. The 
cabinet is Tilled with arm-length rubber 
gloves and is operated under a negative 
pressure of at least 0.5 Inches water gauge. 
All supply air is filtered through HEPA filters. 
Exhaust air is Tillered through two HEPA 
filters or one HEPA filter and incinerator 
before being discharged to the outside 
environment 
Appendix H. — Shipment 
Recombinant DNA molecules 
contained in an organism or vims shall 
be shipped only as an etiologic agent 
under requirements of the U.S. Public 
Health Service, and the U.S. Department 
of Transportation (S 72.3. Part 72. Title 
42. and {( 173.386-.388. Part 173. Title 
49. U.S. Code of Federal Regulations 
(CFR)) as specified below. 
Appendix H-1. Recombinant DNA 
modecules contained in an organism or 
vims requiring PI. P2. or P3 physical 
containment when offered for 
transportation or transported, are 
subject to all requirements of { 72.3(a)- 
(e). Part 72. Title 42 CFR. and 
S{ 173.306- 388. Part 173. Title 49 CFR. 
Appendix H-Il. Recombinant DNA 
molecules contained in an organism or 
vims requiring P4 physical containment 
when offered for transportation or 
transported, are subject to the 
requirements listed above under 
Appendix H-I and are also subject to 
S 72.3(f). Part 72. Title 42 CFR. 
Appendix H-III. Information on 
packaging and labeling of etiologic 
agents is shown in Figures 1, 2. and 3. 
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. 
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