■I 34520 Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Notices 
\ Department of Health, Education, and 
I Welfare, Public Health Service, NIH, 
i U.S. Government Printing Office, Stock 
i' No. 1740-00383, 1974. 
, Appendix G-III-E. A. Heilman, M. N. 
Oxman, and R. Pollack (eds.), 
I Biohazards in Biological Research. Cold 
; Spring Harbor Laboratory 1973. 
I Appendix G-III-F. N. V. Steere (ed ), 
Handbook of Laboratory Safety, 2nd 
' edition. The Chemical Rubber Co., 
Cleveland, Ohio, 1971. 
j Appendix G-III-G. Bodily, J. L, 
“General Administration of the 
I Laboratory,” H. L. Bodily, E. L. Updyke, 
I and J. O. Mason (eds.). Diagnostic 
j Procedures for Bacterial, Mycotic, and 
j Parasitic Infections, American PubUc 
I Health Association, New York, 1970, 
I pp. 11-28. 
I Appendix G-Ill-H. Darlow, H. M. 
i (1969). “Safety in the Microbiological 
j Laboratory,” in J. R. Norris and D. W. 
Robbins (eds.). Methods in 
Microbiology, Academic Press, Inc., 
I New York, pp. 169-204. 
Appendix G-III-I. The Prevention of 
Laboratory Acquired Infection, C. H. 
Collins, E. G. Hartley, and R. Pilsworth, 
' Public Health Laboratory Service, 
Monograph Series No. 6, 1974. 
Appendix G-UI-J. Chatigny, M. A., 
“Protection Against Infection in the 
Microbiological Laboratory: Devices and 
Procedures,” in W. W. Umbreit (ed.). 
Advances in Applied Microbiology, 
Academic Press, New York, New York, 
1961,3:131-192. 
Appendix G-III-K. Horsfall, F. L. Jr., 
and J. H. Baner, Individual Isolation of 
Infected Animals in a Single Room, J. 
Bact., 1940, 40, 569-580. 
Appendix G-m-L. Biological safety 
cabinets referred to in this section are 
classified as Class I, Class II, or Class III 
cabinets. A Class I is a ventilated 
cabinet for personnel protection having 
an inward Dow of air away from the 
operator. The exhaust air from this 
cabinet is filtered through a high 
efficiency particulate air/HEPA filter. 
This cabinet is used in three operational 
modes: (i) with a full-width open front, 
(ii) with an installed front closure panel 
(having four 6-inch diameter openings) 
without gloves, and (iii) with an 
installed fixtnt 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 p>er 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 persoimel 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 op>en 
front is 75 feet per minute or greater. 
Design and performance specifications 
for Class II cabinets have been adopted 
by the National Sanitation Foundation, 
Arm Arbor, Michigan. A Class III 
cabinet is a closed-front ventilated 
cabinet of gas tight construction which 
provides the highest level of personnel 
protection of all biosafety 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 gauge. 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 n (Laminar Flow) Biohazard 
Cabinetry, Ann Arbor, Michigan. 
Appendix G-IU-M. Biosafety Level 1 
is suitable for work involving agents of 
unknovra 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 fltie procedures conducted in 
the laboratory and are supervised by a 
scientist with general training in 
microbiology or a related science (see 
Appendix G-IIl-B). 
Appendix G-III-N. Biosafety Level 2 
is similar to Level 1 and is suitable for 
work involving agents of moderate , 
potential hazard to persormel and the 
environment. It differs in that: (1) 
laboratory personnel have specific 
training in handling pathogenic agents 
and are directed by competent 
scientists; (2) acce^ 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-B). 
Appendix G-III-O. Office of Research 
Safety, National Cancer Institute, and 
the Special Committee of Safety and 
Health Experts, Laboratory Safety 
Monograph: A Supplement to the NIH 
Guidelines for Recombinant DNA 
Research, NIH, Bethesda, Maryland 
1978. 
Appendix G-III-P. Biosafety Level 3 
is applicable to clinical, diagnostic, 
tea<±ing, research, or production 
facilities in which work is conducted 
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 
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 BL3 (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 
w'here facility features satisfy BL2 
recommendations provided the 
recommended “Standard 
Microbiological Practices,” “Special 
Practices," and “Containment 
Equipment” for BL3 are rigorously 
followed. The decision to implement 
this modification of BL3 
recommendations should be made only 
by the Principal Investigator. 
Appendix H. Shipment 
Recombinant DNA molecules 
contained in ah organism or in a viral 
genome shall be shipped under the 
applicable regulations of the U.S. Postal 
Service (39 Code of Federal Regulations, 
Part 3); the Public Health Service (42 
Code of Federal Regulations, Part 72); 
the U.S. Department of Agriculture (9 
Code of Federal Regulations, 
Subchapters D and E; 7 CFR, Part 340); 
and/or the U.S. Department of 
Transportation (49 Code of Federal 
Regulations, Parts 171-179). 
Appendix H-I. Host organisms or 
viruses will bo shipped as etiologic 
agents, regardless of whether they 
contain recombinant DNA, if they are 
regulated as human pathogens by the 
Public Health Service (42 Code of 
Federal Regulations, Part 72) or as 
animal pathogens or plant pests under 
the U.S. Department of Agriculture, 
Animal and Plant Health Inspection 
Service (Titles 9 and 7 Code of Federal 
Reflations, respectively). 
Appendix H-II. Host organisms and 
viruses will be shipped as etiologic 
agents if they contain recombinant DNA 
when: (i) the recombinant DNA includes 
the complete genome of a host organism 
or virus regulated as a human or aniiiid 
Recombinant DNA Research, Volume 19 
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