Federal Register / Vol. 51. No. 88 / Wednesday. May 7, 1986 / Notices 
16S65 
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-C-3-b-(2). Proposed major actions 
of the type falling under Section IV-C- 
1— b — (1) at least 30 days prior to the RAC 
meeting at which they will be 
considered: and 
rV-C-3-b~(3). The N1H director’s final 
decision on recommendations made by 
the RAC. 
rV-C-3-c. Publishing the 
Recombinant DNA Technical Bulletin; 
and 
IV-C-3-d. Serving as executive 
secretary of the RAC. 
IV-C-4. Other N1H Components. 
Other NIH components shall be 
responsible for certifying maximum 
containment (BL4) facilities, inspecting 
them periodically, and inspecting other 
recombinant DNA facilities as deemed 
necessary. 
TV-D — Compliance 
As a condition for NIH funding of 
recombinant DNA -esearch, institutions 
must ensure that such research 
conducted at or sponsored by the 
institution, irrespective of the source of 
funding, shall comply with these 
Guidelines. The policies on 
noncompliance are as follows: 
rV-D- 1 . All NIH-funded projects 
involving recombinant DNA techniques 
must comply with the NIH 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. 
TV-D-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-D-3. Information concerning 
noncompliar ~e with the Guidelines may 
be brought forward by any person. It 
should be delivered to both NIH 
(ORDA) and the relevant Institution. 
The institute n. generally through the 
IBC, shall take appropriate action. The 
institution shall forward a complete 
report of the incident to ORDA, 
recommending any further action. 
TV-D-4. In cases where NIH proposes 
to suspend, limit, or terminate financial 
assistance because of noncompliance 
with the Guidelines, applicable DHHS 
and Public Health Service procedures 
shall govern. 
TV-D-S. 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 and References of Sections 
I-IV 
1. The original reference to organisms as 
Class 1. 2. 3, 4. or S refers to the classification 
in the publication Classification of Etiologic 
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. 
The Director. NIH. with advice of the 
Recombinant DNA Advisory Committee, may 
revise the classification for the purposes of 
these Guidelines (see Section IV-C-l-b-{2)- 
(d]J. The revised list of organisms in each 
class is reprinted in Appendix B to these 
Guidelines. 
2. 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 of his responsibility to "make 
the initial determination of the required 
levels of physical and biological containment 
In accordance with the Guidelines" (Section 
IV-B-5-C— (1)). In the cases falling under 
Sections ID-A. -B or -C. this judgment is to 
be reviewed and approved by the IBC as part 
of its responsibility to make "an independent 
assessment of the containment levels 
required by these Guidelines for the proposed 
research" (Section IV-B-3-a-{l)). If the IBC 
wishes, any specific cases may be referred to 
ORDA as part of ORDA's functions to 
"provide advice to all within and outside 
NIH" (Section IV-C-3), and ORDA may 
request advice from the RAC as part of the 
RAC's responsibility for "interpreting and 
determining containment levels upon request 
by ORDA" (Section IV-C-l-b-{2)-(a)). 
3. Laboratory Safety at the Center for 
Disease Control (Sept. 1974). U.S. Department 
of Health. Education and Welfare Publication 
No. CDC 75-8118. 
4. Classification of Etiologic 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. 
5. 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. 
8. National Institutes of Health Biohazards 
Safety Guide (1974). U.S. Department of 
Health, Education and Welfare. Public Health 
Service. National Institutes of Health. U.S. 
Government Printing Office. Stock No. 1740- 
00383. 
7. Biohazards in Biological Research 
(1973). A. Heilman. M.N. Oxman, and R. 
Pollack (ed.) Cold Spring Harbor Laboratory. 
8. Handbook of Laboratory Sa fety (1971). 
2nd Edition. N.V. Steere (ed.). The Chemical 
Rubber Co.. Cleveland. 
9. 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. 
10. 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. 
11. The Prevention of Laboratory Acquired 
Infection (1974). C.H. Collins. E.G. Hartley, 
and R. Pilsworth. Public Health Laboratory 
Service. Monograph Series No. 8. 
12. 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. 
13. Design Criteria for Virol 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. 
14. Kuehne, R.W. (1973). Biological 
Containment Facility for Studying Infectious 
Disease. Appl. Microbiol. 28-239-243. 
15. Runkle. R.S.. and G.B. Phillips (1969). 
Microbial Containment Control Facilities. 
Van Nostrand Reinhold. New York. 
16. 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. 
17. As classified in the Third Report of the 
International Committee on Taxonomy of 
Viruses: Classification and Nomenclature of 
Viruses, R.E.F. Matthews, Ed. Intervirology 12 
(129-296) 1979. 
18. A USDA permit, required for import and 
Interstate transport of pathogens, may be 
obtained from the Animal and Plant Health 
Inspection Service. USDA Federal Building. 
Hyattsville. MD 20782. 
19. i.e.. the total of all genomes within a 
Family shall not exceed two-thirds of the 
genome. 
20. All activities, including storage of 
variola and whitepox, are restricted to the 
single national facility (World Health 
Organization (WHO) Collaborating Center 
for Smallpox Research, Centers for Disease 
Control, in Atlanta). 
21. Section III— A— 4 covers only those 
experiments in which the intent is to modify 
stably the genome of cells of a human 
subject. Other experiments involving 
recombinant DNA in human subjects such 83 
feeding of bacteria containing recombinant 
DNA or the administration of vaccines 
containing recombinant DNA are not covered 
In Section III-A-4 of the Guidelines. 
22. For recombinant DNA experiments in 
which the intent is to modify stably the 
genome of cells of a human subject, see 
Section III-A-4. 
Recombinant DNA Research, Volume 1 1 
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