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Federal Register / Vol. 44, No. 232 / Friday, November 30, 1979 / Notices 
under conditions of physical 
containment comparable to Pi and 
appropriate to the organism under study 
[2A]. Intact plants or propagative plant 
parts may be grown under Pi conditions 
described under Section II1-C-3. 
Containment must be modified to ensure 
that the spread of pollen, seed or other 
propagules is prevented. This can be 
accomplished by conversion to negative 
pressure in the growth cabinet or 
greenhouse or by physical entrapment 
by “bagging" of reproductive structures. 
Transfers to any other plant organisms 
will be considered on a case-by-case 
basis [45]. 
Ill— D. Complementary DNAs. Specific 
containment levels are given in Section 
III-A-2-a (see also last column of Table 
III) for complementary DNA (cDNA) of 
viral mRNA. For the other Sections of 
the Guidelines, where applicable, 
cDNAs synthesized in vitro are included 
within each of the above classifications. 
For example, cDNAs formed from 
cellular RNAs that are not purified and 
characterized are included under III-A- 
1, shotgun experiments; cDNAs formed 
from purified and characterized RNAs 
are included under IH— A— 3; etc. 
Due to the possibility of nucleic acid 
contamination of enzyme preparations 
used in the preparation of cDNAs, the 
investigator must employ purified 
enzyme preparations that are free of 
viral nucleic acid. 
III— E. Synthetic DNAs. If the synthetic 
DNA segment is likely to [2A] yield a 
potentially harmful polynucleotide or 
polypeptide (e.g., a toxin or a 
pharmacologically active agent), the 
containment conditions must be as 
stringent as would be used for 
propagating the natural DNA 
counterpart. 
If the synthetic DNA sequence codes 
for a harmless product, [2A] it may be 
propagated at the same containment 
level as its purified natural DNA 
counterpart. For example, a synthetic 
DNA segment which corresponds to a 
nonharmful gene of birds, to be 
propagated in Saccharomyces 
cerevisiae, would require P2 physical 
containment plus an HV1 host-vector, or 
P1 + HV2. 
If the synthetic DNA segment is not 
expressed in vivo as a polynucleotide or 
polypeptide product, the organisms 
containing the recombinant DNA 
moleoele are exempt [4] from the 
Guidelines. 
IV. Roles and Responsibilities 
IV- A. Policy. Safety in activities 
involving recombinant DNA depends on 
the individual conducting them. The 
Guidelines cannot anticipate every 
possible situation. Motivation and good 
judgement are the key essentials to 
protection of health and the 
environment. 
The Guidelines are intended to help 
the Institution, the Institutional 
Biosafety Committee (IBC), the 
Biological Safety Officer, and the 
Principal Investigator determine the 
safeguards that should be implemented. 
These Guidelines will never be complete 
or final, since all conceivable 
experiments involving recombinant 
DNA cannot be forseen. Therefore, it is 
the responsibility of the Institution and 
those associated with it to adhere to the 
purpose of the Guidelines as well as to 
their specifics. 
Each Institution (and the IBC acting 
on its behalf) is responsible for ensuring 
that recombinant DNA activities comply 
with the Guidelines. General recognition 
of institutional authority and 
responsibility properly establishes 
accountability for safe conduct of the 
research at the local level. 
The following roles and 
responsibilities constitute an 
administrative framework in which 
safety is an essential and intergral part 
of research involving recombinant DNA 
molecules. Further clarifications and 
interpretations of roles and 
responsibilities will be issued by NIH as 
necessary. 
IV-B. General Applicability. The 
Guidelines are applicable to all 
recombinant DNA research within the 
United States or its territories which is 
conducted at or sponsored by an 
Institution that receives any support for 
recombinant DNA research from NIH. 
This includes research performed by 
NIH directly. 
An individual receiving support for 
research involving recombinant DNA 
must be associated with or sponsored 
by an Institution that can and does 
assume the responsibilities assigned in 
these Guidelines. 
The Guidelines are also applicable to 
projects done abroad if they are 
supported by NIH funds. If the host 
country, however, has established rules 
for the conduct of recombinant DNA 
projects, then a certificate of compliance 
with those rules may be submitted to 
NIH in lieu of compliance with the NIH 
Guidelines. NIH reserves the right to 
withhold funding if the safety practices 
to be employed abroad are not 
reasonably consistent with the NIH 
Guidelines. 
IV-C. General Definitions. The 
following terms, which are used 
throughout the Guidelines, are defined 
as follows: 
IV-C-1. “DNA” means 
deoxyribonucleic acid. 
IV-C-2. “Recombinant DNA” or 
"recombinant DNA molecules” means 
either (i) molecules which are 
constructed outside living cells by 
joining natural or synthetic DNA 
segments to DNA molecules that can 
replicate in a living cell, or (ii) DNA 
molecules which result from the 
replication of a molecule described in (i) 
above. 
IV-C-3. "Memorandum of 
Understanding and Agreement" or 
“MUA" is a document that (i) provides 
to NIH or other Federal funding agency 
an Institution’s certification that the 
recombinant DNA research project 
complies with the NIH Guidelines and 
(ii) contains other essential data as 
required in the Administrative Practices 
Supplement. 
IV-C-4. “Institution" means any 
public or private entity (including 
Federal, State, and local government 
agencies). 
IV-C-5. "Institutional Biosafety 
Committee” or “IBC" means a 
committee that (i) meets the 
requirements for membership specified 
in Section IV-D-2, and (ii) reviews, 
approves, and oversees projects in 
accordance with the responsibilities 
defined in Sections IV-D-2 and -3. 
IV-C-6. "NIH Office of Recombinant 
DNA Activities” or “ORDA” means the 
office within NIH with responsibility for 
(i) reviewing and coordinating all 
activities of NIH related to the 
Guidelines, and (ii) performing other 
duties as defined in Section IV-E-3. 
IV-C-7. "Recombinant DNA Advisory 
Committee” or "RAC" means the public 
advisory committee that advises the 
Secretary, the Assistant Secretary for 
Health, and the Director of the National 
Institutes of Health concerning 
recombinant DNA research. The RAC 
shall be constituted as specified in 
Section IV-E-2. 
IV-C-6. “Director, NIH" or “Director” 
means the Director of the National 
Institutes of Health and any other officer 
or employee of NIH to whom authority 
has been delegated. 
IV-C-9. “Federal Interagency 
Advisory Committee on Recombinant 
DNA Research” means the committee 
established in October 1976 to advise 
the Secretary, HEW, the Assistant 
Secretary for Health, and the Director, 
NIH, on the coordination of those 
aspects of all Federal programs and 
activities which relate to recombinant 
DNA research. 
IV-C-10. "Administrative Practices 
Supplement” or “APS” means a 
publication to accompany the NIH 
Guidelines specifying administrative 
procedures for use at NIH and at 
Institutions. 
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