Federal Register / Vol. 49, No. 227 / Friday, November 23, 1984 / Notices 
46273 
any or all recombinant DNA projects at 
the Institution. 
IV-D-2. A1J non-NIH funded projects 
involving recombinant DNA techniques 
conducted at or sponsored by an 
Institution that receives N1H 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. 
1V-D-3. Information concerning 
noncompliance with the Guidelines 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. 
IV-C-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. 
See Appendix J for information on the 
Federal Interagency Advisory 
Committee on Recombinant DNA 
Research. 
IV-D-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 and Reference of Sections I-IV 
(7) The original reference to organism* as 
Class 1, 2, 3, 4. or 5 refers to the classification 
in the publication Classification of Eliologic 
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)). 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 • 
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 
I V— B — 5 — c — ( 1 ) ) . In the cases falling under 
Sections 1 1 1 — A, -B or -C, this judgment is to 
be reviewed and approved by the LBC as part 
of its responsibility to make “an independent 
assessment of the containment level* 
required by these Guklelinea for the proposed 
research" (Section IV-B-3-e-(l)). If the IBC 
wishes, any specific cases may be referred to 
ORDA as part of ORDA'a function* 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 75-6118. 
(4) Classification of Eliologic 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) Notional Cancer Institute Safety 
Standards for Research Involving Oncogenic 
Viruses (Oct. 1974). U.S. Department of 
Health, Education and Welfare Publication 
No. (NIH) 75-790. 
(6) 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 
{1973J. A. Heilman, M. N. Oxman, and R. 
Pollack (ed.) Cold Spring Harbor Laboratory. 
(fl) Handbook of Laboratory Safety (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.), 
Diagnisitic 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 ). 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. EL Collins, B. G. 
Hartley, and R. Pflsworth. Public Health 
Laboratory Service, Monograph Series No. 0. 
(12) Chatigny, M. A. (1961). Protection 
Against Infection in the Microbiological 
Laboratory: Devices and Procedures. In W. 
W. Umbreft (ed.). Advances in Applied 
Microbiology. Academic Press, New York, 
N.Y. 3.-131-192. 
(13) 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. 
(11) Kuehne, R. W. (1973). Biological 
Containment Facility for Studying Infectious 
Disease. Appl. Microbiol. 26-239-243. 
(15) Runkle, R. S, and C. B. Phillips (1969). 
Microbial Containment Control Facilities. 
Van Nostrand Reinhold, New York. 
(16) Gatigny, 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. 
[16] 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. 
(10) 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 UI-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 as 
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 IH-A-4. 
VLVoluntary Compliance 
VI- A. Basic Policy. Individuals, 
corporations, and institutions not 
otherwise covered by the Guidelines are 
encouraged to do so by following the 
standards and procedures set forth in 
Parts I-IV of the Guidelines. In order to 
simplify discussion, references hereafter 
to “institutions” are intended to 
encompass corporations, and 
individuals who have no organizational 
affiliation. For purposes of complying 
with the Guidelines, an individual 
intending to carry out research involving 
recombinant DNA is encouraged to 
affiliate with an institution that has an 
IBC approved under the Guidelines. 
Since comm eric al organizations have 
special concerns, such as protection of 
proprietary data, some modifications 
and explanations of the procedures in 
Parts k-lV are provided below, in order 
to address these concerns. 
VI-B. IBC Approval. ORDA will 
review the membership of an 
institution's IBC and where it finds the 
IBC meets the requirements set forth in 
Section IV-B-2 will give its approval to 
the IBC membership. 
It should be emphasized that 
employment of an IBC member solely 
for purposes of membership on the IBC 
does not itself make the member an 
institutionally affiliated member for 
purposes of Section IV-B-2-a. 
Except for the unaffiliated members, a 
member of an IBC for an institution not 
otherwise covered by the Guidelines 
may participate in the review and 
approval of a project in which the 
[ 270 ] 
