Federal Register / Vol. 49, No. 80 / Tuesday, April 24, 1984 / Notices 
17679 
separate building or a clearly demarcated 
and isolated zone within a building. Outer 
and inner change rooms separated by a 
shower are provided for personnel entering 
and leaving the facility. A double-doored 
autoclave, fumigation chamber, or ventilated 
airlock is provided for passage of those 
materials, supplies, or equipment which are 
not brought into the facility through the 
change room. 
Appendix G-ll-D—4-b. Walls, floors, and 
ceilings of the facility are constructed to form 
a sealed internal shell which facilitates 
fumigation and is animal and insect proof. 
The internal surfaces of this shell are 
resistant to liquids and chemicals, thus 
facilitating cleaning and decontamination of 
the area. All penetrations in these structures 
and surfaces are sealed. Any drains in the 
floors contain traps filled with a chemical 
disinfectant of demonstrated efficacy against 
the target agent, and they are connected 
directly to the liquid waste decontamination 
system. Sewer and other ventilation lines 
contain HEPA filters. 
Appendix G-lI-D-4-c. Internal facility 
appurtenances, such as light fixtures, air 
ducts, and utility pipes, are arranged to 
minimize the horizontal surface area on 
which dust can settle. 
Appendix G-Il-D-4-d. Bench tops have 
seamless surfaces which are impervious to 
water and resistant to acids, alkalis, organic 
solvents and moderate heat. 
Appendix C-I/-D --4 e. Laboratory furniture 
is of simple and sturdy construction, and 
spaces beteen benches, cabinets, and 
equipment are accessible for cleaning. 
Appendix G-Il-D-4-f. A foot, elbow, or 
automatically operated handwashing sink is 
provided near the door of each laboratory 
room in the facility. 
Appendix G-U-D-4-g. If there is a central 
vacuum system, it does not serve areas 
outside the facility. In-line HEPA filters are 
placed as near as practicable to each use 
point or service cock. Filters 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 G-U-D—4-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 backflow-protected 
distribution system supplying water to the 
laboratory areas. 
Appendix G-ll-D-4-i. Access doors to the 
laboratory are self-closing and lockable. 
Appendix G-II-D—l-j. And windows are 
breakage resistant. 
Appendix G-Il-D—4-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-II-D—4-1. 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-Il-D—t-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-lI-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-Il-D-4-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 testing 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 G-II-D-4-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 treated exhaust air from Class 
III 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 any 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-Il-D-4-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. 
j. The following modifications would 
be made in Appendix G-III. Footnotes 
and References of Appendix G: 
(1) The second footnote in Appendix 
G-III, Footnotes and References of 
Appendix G would be deleted. The 
following language would be 
substituted: 
2. Biosafety in Microbiological and 
Biomedical Laboratories, U.S. Department of 
Health and Human Services (April 1984). 
Centers for Disease Control, Atlanta, Georgit 
30333, and National Institutes of Health, 
Bethesda, Maryland 20205. 
(2) The following language would be 
added to the end of Appendix G — III— 12: 
National Sanitation Foundation Standard 
49. 1976. Class II (Laminar Flow) Biohazard 
Cabinetry. Ann Arbor, Michigan. 
(3) The following footnotes would be 
added to Appendix G-III: 
13. Biosafety Level 1 is suitable for work 
involving agents of no known or minimal 
potential hazard to laboratory personnel and 
the environment. The laboratory is not 
separated from the general traffic patterns in 
the building, work is generally conducted on 
open bench tops. Special containment 
equipment is not required or generally used. 
Laboratory personnel have specific training 
in the procedures conducted in the laboratory 
and are supervised by a scientist with 
general training in microbiology or a related 
science (See Appendix G — III— 2). 
14. Biosafety Level 2 is similar to Level 1 
and Is suitable for work involving agents of 
moderate potential hazard to personnel and 
the environment. It differs in that (1) 
laboratory personnel have specific training in 
handling pathogenic agents and are directed 
by competent scientists, (2) access to the 
laboratory is limited when work Is being 
conducted, and (3) certain procedures in 
which infectious aerosols are created are 
conducted in biological safety cabinets or 
other physical containment equipment (See 
Appendix G — III— 2). 
15. Office of Research Safety, National 
Cancer Institute, and the Special Committee 
of Safety and Health Experts. 1978. 
Laboratory Safety Monograph: A Supplement 
to the NIH Guidelines for Recombinant DNA 
Research. Bethesda. Maryland, National 
Institutes of Health. 
r 399] 
