Federal Register / Vol. 51, No. 88 / Wednesday, May 7, 1986 / Notices 
16977 
are installed to permit in-place 
decontamination and replacement. 
Other liquid and gas services to the 
facility are protected by devices that 
prevent backflow. 
Appendix C-Il-D—t-h. If water 
fountains are provided, they are foot 
operated and are located in the facility 
corridors outside the laboratory. The 
water service to the fountain is not 
connected to the backfiow-protccted 
distribution system supplying water to 
the laboratory areas. 
Appendix G-II-D-t-i. Access doors to 
the laboratory are self-closir.g and 
lockable. 
Appendix C-ll-D—t-j. Any windows 
are breakage resistant. 
Appendix G-II-D—t-k. A double- 
doored autoclave is provided for 
decontaminating materials passing out 
of the facility. The autoclave door which 
opens to the area external to the facility 
is sealed to the outer wall and 
automatically controlled so that the 
outside door can only be opened after 
the autoclave "sterilization" cycle has 
been completed. 
Appendix G-lI-D-A-l. A pass-through 
dunk tank, fumigation chamber, or an 
equivalent decontamination method is 
provided so that materials and 
equipment that cannot be 
decontaminated in the autoclave can be 
safely removed from the facility. 
Appendix G-U-D-4-m. Liquid 
effluents from laboratory sinks, 
biological safety cabinets, floors, and 
autoclave chambers are decontaminated 
by heat treatment before being released 
from the maximum containment facility. 
Liquid wastes from shower rooms and 
toilets may be decontaminated with 
chemical disinfectants or by heat in the 
liquid waste decontamination system. 
The procedure used for heat 
decontamination of liquid wastes is 
evaluated mechanically and biologically 
by using a recording thermometer and 
an indicator microorganism with a 
defined heat susceptibility pattern. If 
liquid wastes from the shower room are 
decontaminated with chemical 
disinfectants, the chemical used is of 
demonstrated efficacy against the target 
or indicator microorganisms. 
Appendix G-II-D-4-n. An Individual 
supply and exhaust air ventilation 
system is provided. The system 
maintains pressure differentials and 
directional airflow as required to assure 
flows inward from areas outside of the 
facility toward areas of highest potential 
risk within the facility. Manometers are 
used to sense pressure differentials 
between adjacent areas maintained at 
different pressure levels. If a system 
malfunctions, the manometers sound an 
alarm. The supply and exhaust airflow 
is interlocked to assure inward (or zero) 
airflow at all times. 
Appendix G-lI-D—J~o. The exhaust 
air from the facility is filtered through 
HEPA filters and discharged to the 
outside so that it is dispersed away from 
occupied buildings and air intakes. 
Within the facility, the filters are located 
as near the laboratories as practicable 
in order to reduce the length of 
potentially contaminated air ducts. The 
filter chambers are designed to allow in 
situ decontamination before filters are 
removed and to facilitate certification 
tasting after they are replaced. Coarse 
filters and HEPA filters are provided to 
treat air supplied to the facility in order 
to increase the lifetime of the exhaust 
HEPA filters and to protect the supply 
air system should air pressures become 
unbalanced in the laboratory. 
Appendix C-lI-D-i-p The treated 
exhaust air from Class I and II biological 
safety cabinets can be discharged into 
the laboratory room environment or the 
outside through the facility air exhaust 
system. If exhaust air from Class I or II 
biological safety cabinets is discharged 
into the laboratory the cabinets are 
tested and certified at 6-month intervals. 
The exhaust air from Class 111 biological 
safety cabinets is discharged, without 
recirculation through two sets of HEPA 
filters in series, via the facility exhaust 
air system. If the treated exhaust air 
from ary of these cabinets is discharged 
to the outside through the facility 
exhaust air system, it is connected to 
this system in a manner (e g . thimble 
unit connection [12]) that avoids any 
interference with the air balance of the 
cabinets or the facility exhaust air 
system. 
Appendix G-ll-D-f-q. A specially- 
designed suit area may be provided in 
the facility. Personnel who enter this 
area wear a one-piece positive pressure 
suit that is ventilated by a life-support- 
system. The life-support system includes 
alarms and emergency backup breathing 
air tanks. Entry to this area is through 
an airlock fitted with airtight doors. A 
chemical shower is provided to 
decontaminate the surface of the suit 
before the worker leaves the area. The 
exhaust air from the suit area is filtered 
by two sets of HEPA filters installed in 
series. A duplicate filtration unit, 
exhaust fan. and an automatically 
starting emergency power source are 
provided. The air pressure within the 
suit area is lower than that of any 
adjacent area. Emergency lighting and 
communication systems are provided. 
All penetrations into the internal shell of 
the suit area are sealed. A double- 
doored autoclave is provided for 
decontaminating waste materials to be 
removed from the suit area. 
Table 1.— Possible Alternate Combina- 
tions of Physical and Biological Con- 
tainment Safeguards 
C'assif*C3t>on of 
ph^vcai and 
b«c »og*cal 
COniamrrmnt 
A gnate physical containment 
Alter- 
nate 
brc'ogi- 
cal 
contain- 
ment 
Labora- 
tory 
facilities 
labora- 
tory 
prac 
bees 
Conta.n- 
ment 
equip- 
ment 
813 HV2 
813 
Bl3 
8L3 
HV2 
0L3 
8L3 
814 
HV1 
BL3HV1 . , 
813 
Bl3 
eu 
HV1 
BL3 
813 
812 
HV2 
BL4'HV1 
6'.4 
814 
Bl4 
HV1 
814 
814 
813 
HV2 
Appendix G-III — Footnotes and 
References of Appendix C 
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. Biosafety in Microbiological and 
Biomedical Laboratories. 1st Edition (March 
1984). U S. Dapartment of Health and Human 
Services. Public Health Service. Centers fur 
Disease Control. Atlanta. Georgia 30333. and 
National Institutes of Health. Bcthesda. 
Maryland 20205. 
3. National Career Institute Safety- 
Standards for Research Involving Oncogenic 
Viruses (Oct. 1974). L'.S. Department of 
Health. Education and Welfare Publication 
No. (NIH) 75-790. 
4. National Institutes of Health Biohazards 
Safety Cuide (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 Biohazc rds in Biological Research 
(1973). A. Heilman. M.N. Oxman. and R 
Pollack (ed.) Cold Spring Harbor Laboratory. 
6 Handbook of Laboratory Safety (1971). 
2nd Edition. N.V. Steere (ed.). The Chemical 
Rubber Co.. Cleveland. 
7. Bodily. J.L. (197o). Genera! 
Administration of the Laboratory. H.L. 
Bodily. E.L. Ifpdyke. 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. Pilswcrth. Public Health Laboratory- 
Service. Monograph Series No. 6. 
10. Chatigr.y. M.A. (1961). Protection 
Against Infection in the Microbiological 
Laboratory: Devices and Procedures. In 
WAV. Umb.-eit (ed.). Advances in Applied 
Microbiology. Academic Press. New York 
N.Y. 3:131-192. 
11. Horsfall. F.L.. Jr.. 8nd J.H. Bar.er (1940). 
Individual Isolation of Infected Animals in c 
Single Room. J. Bact. 40. 569-580. 
12. Biological safety cabinets referred to in 
this section are classified as Class I. Class II. 
or Class III cabinets. A Class / is a ventilated 
cabinet for personnel protection having an 
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