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Federal Register / VoL 49, No. 227 / Friday, November 
and equipment that cannot be 
decontaminated in the autoclave can be 
safely removed from the facility. 
"Appendix G-II-D-4-m. Liquid 
effluents from laboratory sinks, 
biological safety cabinets. Doors, 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 ofTiquid 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 C-n-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 
diafferent 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-ff-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 ibe 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 1 and U 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 11 
biological safety cabinets is discharged 
into the laboratory the cabinets are 
tested Mid certified at 6-month intervals. 
The treated exhaust air from Class HI 
biological safety cabinets is discharged. 
without recirculation through two sets 
of HEPA filters in aeries, 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-II-D— 4— q. A specifically 
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 fillers 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 fighting and 
communication system are provided. All 
penetratins 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 are 
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 is deleted. The following 
language is substituted: 
“2. Biosafety in Microbiological and 
Biomedical Laboratories, 1st Edition 
(March 1984) U.S. Department of Health 
and Human Services. Public Health 
Service. Centers for Disease Control, 
Atlanta, Georgia 30333, and National 
Institutes of Health, Bethesda, Maryland 
20205." 
(2) The following language 46 added to 
the end of Appendix G-LU-12: 
“National Sanitation Foundation 
Standard 49. 1976. Class 11 (Laminar 
Flow) Biohazard Cabinetry. Arm Arbor, 
Michigan." 
(3) The following footnotes are 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 
23, 1984 / Notices 
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 <if 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-MI-2). 
“15. Office of Research Safety, 
National Cancer Institute, and the 
Special Committee of Safety and Health 
Experts. 1978. ‘Laboratory Safely 
Monograph: A Supplement to the NIH 
Guidelines for Recombinant DNA 
Research.’ Bethesda, Maryland, 
National Institutes of Health. 
~10. Biosafety Level 3 is applicable to 
clinical, diagnostic, teaching, research, 
or production facilities in which work is 
done with indigenous or exotic agents 
which may cause serious or potentially 
lethal disease as a result of exposure by 
the inhalation route. Laboratory 
personnel have specific training in 
handling pathogenic And potentially 
lethal agents and are supervised by 
competent scientists who are 
experienced in working with these 
agents. All procedures involving the 
manipulation of infectious material are 
conducted within biological safety 
cabinets or other physical containment 
devices or by personnel wearing 
appropriate peraonal protective clothing 
and devioes. The laboratory has special 
engineering and design features. It is 
recognized, however, (bat many existing 
facilities may not have all the facility 
safeguards recommended for Biosafety 
Level 3 (e.g., access zone, sealed 
penetrations, and directional airflow, 
etc.). In these circumstances, acceptable 
safety may be achieved for routine or 
repetitive operations (e.g., diagnostic 
procedures involving the propagation of 
an agent for identification, typing, and 
susceptibility testing) in laboratories 
where facility features satisfy Biosafety 
Level 2 recommendations provided ihe 
recommended 'Standard Microbiological 
Practicea,' ‘Special Practices,’ and 
‘Containment Equipment’ for Biosafety 
Level 3 are rigorously fallowed. The 
decision to implement this modification 
of Biosafety Level 3 recommendations 
[ 260 ] 
