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Federal Register / Vol. 47, No. 77 / Wednesday, April 21, 1982 / Notices 
(RAC) meetings and agendas at least 30 
days in advance; 
Nota. — 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. 
rV-E-3-b-{2). Proposed major actions 
of the type falling under Section IV-E-1- 
b-(l) at least 30 days prior to the RAC 
meeting at which they will be 
considered; and 
rV-E-3-b-(3). The NIH Director's final 
decision on recommendations made by 
the RAC. 
rV-E-3-c. Publishing the Recombinant 
DNA Technical Bulletin; and 
IV-E-3-d. Serving as executive 
secretary of the RAC 
IV-E-4. Other NIH Components. 
Other NIH components shall be 
responsible for 
rV-E-4-a. Certifying P4 facilities, 
inspecting them periodically, and 
inspecting other recombinant DNA 
facilities as deemed necessary; and 
rV-E-4-b. Announcing and 
distributing certified HV2 host-vector 
systems (see Section U-D-3). 
rV-F. Compliance. As a condition for 
NIH funding of recombinant DNA 
research, Institutions must ensure that 
such research conducted at or 
sponsored by the Institution, 
inespective of the source of funding, 
shall comply with these Guidelines. The 
policies on noncompliance are as 
follows: 
rV-F-1. All NIH-funded projects 
involving recombinant DNA techniques 
must comply with the NTH Guidelines. 
Noncompliance may result in (i) 
suspension, limitation, or termination of 
financial assistance for such projects 
and of NIH funds for other recombinant 
DNA research at the Institution, or (ii) a 
requirement for prior NIH approval of 
any or all recombinant DNA projects at 
the Institution. 
rV-F-2. All non-NIH funded projects 
involving recombinant DNA techniques 
conducted at or sponsored by an 
Institution that receives NIH funds for 
projects involving such techniques must 
comply with the NIH Guidelines. 
Noncompliance may result in (i) 
suspension, limitation, or termination of 
NIH funds for recombinant DNA 
research at the Institution, or (ii) a 
requirement for prior NIH approval of 
any or all recombinant DNA projects at 
the Institution. 
IV-F-3. Information concerning 
noncompliance with the Guildelines 
may be brought forward by any person. 
It should be delivered to both NIH 
(ORDA) and the relevant Institution. 
The Institution, generally through the 
IBC. shall take appropriate action. The 
Institution shall forward a complete 
report of the incident to ORDA. 
recommending any further action 
indicated. 
IV-F-4. In cases where NIH proposes 
to suspend, limit, or terminate financial 
assistance because of noncompliance 
with the Guidelines, applicable DHEW 
and Public Health Service Procedures 
shall govern. 
rV-F-5. Voluntary Compliance. Any 
individual, corporation, or institution 
that is not otherwise covered by the 
Guidelines is encouraged to conduct 
recombinant DNA research activities in 
accordance with the Guidelines, through 
the procedures set forth in Part VI. 
V. Footnotes end References 
1. The reference to organisms as Class 1, 2, 
3. 4. or 5 refers to the classiFication in the 
publication Classification ofEtiologic Agents 
on the Basis of Hazard. 4(h Edition. July 1974: 
U.S. Department of Health. Educatioa and 
Welfare. Public Health Service. Centers for 
Disease Control. Offlce of Biosafety. Atlanta, 
Georgia 30333. The list of organisms in each 
class, as given in this publication, is reprinted 
in Appendix B to these Guidelines. 
The Director. NIH with advice of the 
Recombinant DNA Advisory Committee, may 
designate certain of the agents which are 
listed as Class 2 in the Classification of 
Etiologic Agents on the Basis of Hazard. 4th 
Edition. )uly 1974. as Class 1 agents for the 
Purposes of these Guidelines (see Section fV- 
E-l-b-(2)-(d)). An updated list of such agents 
may be obtained from the OfTice of 
Recombinant DNA Activities (ORDA), 
National Institutes of Health. Bethesda. 
Maryland 20205. 
The entire Classification of Etiologic 
Agents on the Bosis of Hazard is in the 
process of revision. 
2A. In Part III of the Guidelines, there are a 
number of places where judgments are to be 
made. In all these cases the principal 
investigator is to make the judgment on these 
matters as part on his responsibility to "make 
the initial determination of the required 
levels of physical and biological containment 
in accordance with the Guidelines” (Section 
rV-D-5-c-(l)). In the cases falling under 
Sections lU-A. -B or -C. this judgment is to 
be reviewed and approved by the 
Institutional Biosafety Committee as part of 
its responsibility to make "an independent 
assessment of the containment levels 
required by these Guidelines for the proposed 
research" (Section IV-D-3-a-{l)). If the IBC 
wishes, any specific cases may be referred to 
the NIH O^ice of Recombinant DNA 
Activities as part of ORDA's functions to 
"provide advice to all within and outside 
NIH” (Section IV-E-3). and ORDA may 
request advice from the Recombinant DNA 
Advisory Committee as part of the RAC’s 
responsibility for "interpreting and 
determining containment levels upon request 
by ORDA" (Section IV-E-l-b-(2)^a)). 
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 Etiologic Agents oh 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. Steerefed.). 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 Fhiblic 
Health Association. New York. pp. 11-28. 
13. Darlow, H. M. (1989). 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. Pilsworth. 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 Criteria 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 |. H. Baner 
(1940). Individual Isolation of Infected 
Animals in a Single Room. J. Bad. 40. 569- 
580. 
20. Biological safety cabinets referred to in 
this section are classified as Class I. Class //, 
or Class HI 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 6-inch diameter openings) 
without gloves, and (3) with an installed front 
closure panel equipped with arm-length 
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