Federal Register / Vol. 49, No. 227 / Friday, November 23, 1984 / Notices 
46285 
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-efficicncy 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. The face velocity of the 
inward flow of air through the full-width open 
front is 75 feet per minute or greater. 
A Class II 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 filtered through a 
HEPA filter. The face velocity of the inward 
flow of air through the full-width open front is 
75 feet per minute or greater. Design and 
performance specifications for Class II 
cabinets have been adopted by the National 
Sanitation Foundation, Ann Arbor, Michigan. 
A Class /// 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 fitted with arm-length rubber 
gloves and is operated under a negative 
pressure of at least 0.5 inches water guage. 
All supply air is filtered through HEPA filters. 
Exhaust air is filtered through two HEPA 
filters or one HEPA filter and incinerator 
before being discharged to the outside 
environment. National Sanitation Foundation 
Standard 49. 1976. Class II (Laminar Flow) 
Biohazard Cabinetry. Ann Arbor, Michigan. 
(73) 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). 
(74) 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). 
(75) Office of Reseach 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. 
(76) 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 
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 physicial containment devices or by 
personnel wearing appropriate personal 
protective clothing and devices. The 
laboratory has special engineering and design 
features. It is recognized, however, that 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 
the recommended “Standard Microbiological 
Practices," “Special Practices," and 
"Containment Equipment" for Biosafety Level 
3 are rigorously followed. The decision to 
implement this modification of Biosafety 
Level 3 recommendations should be made 
only by the laboratory director (see Appendix 
G — III— 2). 
Appendix H — Shipment 
Recombinant DNA molecules 
contained in an organism or virus shall 
be shipped only as an etiologic agent 
under requirements of the U.S. Public 
Health Service, and the U.S. Department 
of Transportation (Section 72.3, Part 72, 
Title 42, and Sections 173.386-.388, Part 
173, Title 49, U.S. Code of Federal 
Regulations (CFR)) as specified below: 
Appendix H-l. Recombinant DNA 
molecules contained in an organism or 
virus requiring BLl, BL2, or BL3 physical 
containment, when offered for 
transportation or transported, are 
subject to all requirements of Section 
72.3(a)-(e), Part 72, Title 42 CFR, and 
Sections 173.386-.388, Part 173, Title 49 
CFR. 
Appendix H~II. Recombinant DNA 
molecules contained in an organism or 
virus requiring BL4 physical 
containment, when offered for 
transportation or transported, are 
subject to the requirements listed above 
under Appendix H-I and are also 
subject to Section 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 the Office of Recombinant DN/ 
Activities and in Biosafety in 
Microbiological and Biomedical 
Laboratories (see Appendix G — III— 2j 
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