Federal Register / Vol. 46. No. 233 / Friday. December 4. 1981 / Notices 
59377 
environment, public health, occupational 
health, or related fields. Representatives 
from Federal agencies shall serve as 
nonvoting members. Nominations for the 
RAC may be submitted to the NIH 
Office of Recombinant DNA Activities, 
Bethesda, Md. 20205. 
All meetings of the RAC will be 
announced in the Federal Register, 
including tentative agenda items, 30 
days in advance of the meeting, with 
final agendas (if modified) available at 
least 72 hours before the meeting. No 
item defined as a major action under 
Section IV-E-l-b-(l) may be added to 
an agenda after it appears in the Federal 
Register. 
lV-E-2-a. The RAC shall be 
responsible for advising the Director, 
NIH, on the actions listed in Section IV- 
E-l-b-(I) and -(2). 
rV-E^. The Office of Recombinant 
DNA Activities. ORDA shall serve as a 
focal point for information on 
recombinant DNA activities and provide 
advice to all within and outside NIH, 
including Institutions, Principal 
Investigators, Federal agencies. State an 
local governments, and institutions in 
the private sector. ORDA shall carry out 
such other functions as may be 
delegated to it by the Director, NIH, 
including those authorities described in 
Section IV-E-l-b-(3). In addition, 
ORDA shall be responsible for the 
following: 
IV-E-3-a. through IV-E-3-c-(3). 
[Deleted] 
IV-E-3-c-(4). Publish in the Federal 
Register announcements of RAC 
meetings and agendas 30 days in 
advance on any action listed in Section 
IV-E-l-b-(l) and Section IV-E-l-b-(2). 
Note. — If the agenda for an RAC meeting is 
modified, ORDA shall make the revised 
agenda available to anyone, upon request, at 
least 72 hours in advance of the meeting. 
IV-E-3-c-(5). Publish the 
Recombinant DNA Technical Bulletin; 
and 
IV-E-3-c-(6). Serve as executive 
secretary to the RAC. 
IV-E-4. Other NIH Components. 
Other NIH components shall be 
responsible for: 
IV-E-^a. [Deleted] 
rV-E-4-b. [Deleted] 
IV-E-4-C. Announcing and 
distributing certified HV2 and HV3 host- 
vector systems (see Section II-E-3). 
IV-F. [Deleted] 
IV-G. [Deleted] 
V. Footnotes and References 
(l)-(4) [Deleted] 
(5) Care should be taken to inactivate 
recombinant DNA before disposal. 
Procedures for inactivating DNA can be 
found in the "Laboratory Safety Monograph: 
A Supplement to the NIH Guidelines for 
Recombinant DNA Research.” 
(6) Laboratory Safety at the Center for 
Disease Control (Sept. 1974). U.S. Department 
of Health, Education and Welfare Publication 
No. CDC 75-8118. 
(7) Classification of Etiological Agents on 
the Basis of Hazard (4th Edition. July 1974). 
U.S. Department of Health, Education and 
Welfare. Public Health Service. Centers for 
Disease Control. Office of Biosafety, Atlanta, 
Georgia 30333. 
(8) National Cancer Institute Safety 
Standards for Research Involving Oncogenic 
Viruses (Oct. 1974). U.S. Department of 
Health, Education and Welfare Publication 
No. (NIH) 75-790. 
(9) National Institutes of Health 
Biohazards Safety Guide (1974). U.S. 
Department of Health, Education, and 
Welfare, Public Health 
(10) Biohazards in Biological Research 
(1973). A. Heilman, M. N. Oxman, and R. 
Pollack (ed.) Cold Spring Harbor Laboratory. 
(11) Handbook of Laboratory Safety (1971). 
Second Edition. N. V Steere (ed.). The 
Chemical Rubber Co., Cleveland. 
(12) Bodily, J. L. (1970). General 
Administration of the Laboratory, H. L. 
Bodily, E. L. Updyke, and J. O. Mason (eds.). 
Diagnostic Procedures for Bacterial Mycotic 
and Parasitic Infections. American Public 
Health Association, New York, pp. 11-28. 
(13) 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. 
(14) The Prevention of Laboratory 
Acquired Infection (1974). C. H. Collins, E. G. 
Hartley, and R. Pilsworlh. Public Health 
Laboratory Service, Monograph Series No. 6. 
(15) Chatigny, M. A. (1961). Protection 
Against Infection in the Microbiological 
Laboratory: Devices and Procedures. In W. 
W. Umbreit (ed.). Advances in Applied 
Microbiology. Academic Press. New York, 
N.Y. 3:131-192. 
(16) Design Griteria for Viral Oncology 
Research Facilities (1975). U.S. Department of 
Health, Education and Welfare, Public Health 
Service, National Institutes of Health, DHEW 
Publication No. (NIH) 75-891. 
(17) Kuehne, R. W. (1973. Biological 
Containment Facility for Studying Infectious 
Disease. Appl. Microbiol. 26-239-243. 
(18) Runkle, R. S., and G. B. Phillips (1969). 
Microbial Containment Control Facilities. 
Van Nostrand Reinhold, New York. 
(19) Chatigny, M. A„ and D. I. Clinger 
(1969). Contamination Control in 
Aerobiology. In R. L. Dimmick and A. B. 
Akers (eds,). An Introduction to Experimental 
Aerobiology. John Wiley & Sons, New York, 
pp. 194-263. 
(19A) Horsfall, F. L., Jr., and J. H. Baner 
(1940). Individual Isolation of Infected 
Animals in a Single Room. J. Bact. 40, 569- 
580. 
(20) 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 
inward flow 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: (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 
//cabinet is a ventilated cabinet for 
personnel and product protection having an 
open front with inward air flow for personnel 
protection, and HEIPA 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 HI 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 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. 
(21) Hershfield, V., H. W Boyer, C. 
Yanofsky, M. A. Lovett, and D. R. Helinski 
(1974). Plasmid CoiEi as a Molecular Vehicle 
for Cloning and Amplification of DNA. Proc. 
Nat. Acad. Sci. USA 71 3455-3459. 
(22) Wensink, P. C., D. J. Finnegan, J. E. 
Donelson, and D. S. Hogness (1974), A System 
for Mapping DNA Sequences in the 
Chromosomes of Drosophila Melanogaster. 
Cell 3. 315-335. 
(23) Tanaka, T„ and B. Weisblum (1975). 
Construction of a Colicin El-R Factor 
Composite Plasmid In Vitro: Means for 
Amplification of Deoxyribonucleic Acid. J. 
Bacteriol. 121, 354-362. 
(24) Armstrong, K. A„ V Hershfield, and D. 
R. Helinski (1977). Gene Cloning and 
Containment Properties of Plasmid Col El 
and Its Derivatives, Science 196, 172-174. 
(23) Bolivar, F., R. L. Rodriguez, M. C. 
Betlach, and H. W Boyer (1977). Construction 
and Characterization of New Cloning 
Vehicles: I. Ampicillin-Resistant Derivative 
ofpMB9. Gene 2, 75-93. 
(26) Cohen, S. N„ A. C. W Chang, H. Boyer,; j 
and R, Helling (1973), Construction of 
Biologically Functional Bacterial Plasmids in.\ 
Vitro. Proc. Natl. Acad. Sci. USA 70, 3240- 
3244. 
(27) Bolivar, F., R. L. Rodriguez, R. J, 
Greene, M. C, Batlach, H. L. Reyneker, H, W. ■' 
Boyer, J. H. Crosa, and S. Falkow (1977). 
Construction and Characterization of New 
Cloning Vehicles: II A Multi-Purpose Cloning'4 
System. Gene 2, 95-113. ij 
(23) Thomas, M., J. R. Cameron, and R, W. i| 
Davis (1974). Viable Molecular Hybrids of 
Bacteriophage Lambda and Eukaryotic DNA, 
Proc. Nat. Acad. Sci. USA 71, 4579-4583. 
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