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Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 199-1 / Notices 
Section IV-C-l-b-(2)-(e), Revising 
the Classification of Etiologic Agents for 
the purpose of these NIH Guidelines 
(see Section V-A). 
Section IV-C-l-b-(2}-{f). Interpreting 
the NIH Guidelines for experiments to 
which the NIH Guidelines do not 
specifically assign containment levels; 
Section iV-C-l-b-(2)-(g). Setting 
containment under Sections lll-C-l-d 
and III-C-2-b; 
Section lV-C-l-b-|2)-{h). Approving 
minor modifications o( already certified 
host-vector systems (the standards and 
procedures for such modifications are 
described in Appendix I-ll); 
Section IV-C-l-b-(2}-(i)- 
Decertifying already certified host- 
vector systems; 
Section IV-C-l-b-(2)-(j). Adding 
new entries to the list of molecules toxic 
for vertebrates (see Appendix F); and 
Section lV-C-l-b-(2)-(h). 
Determining appropriate containment 
conditions for experiments according to 
case precedents developed under 
Section IV-C-l-b-(2)-(c). 
The amended version of Section IV- 
C-2 reads as follows: 
Section IV-C-2. Recombinant DNA 
Advisory Committee (RAC). The ICAC 
shall be responsible for advising the 
Director, NIH, on the actions listed in 
Section IV-C-l-b-(l). 
The amended version of Section IV- 
C-3 reads as follows: 
Section IV-C-3. Office of Recombinant 
DNA Activities (ORDA) 
ORDA shall serve as a focal point for 
information on recombinant DNA 
activities and provide advice to .all 
within and outside NIH including 
institutions. Biological Safety Officers, 
Principal Investigators, Federal 
agencies, state and local governments, 
and institutions in the private sector 
ORDA shall carry’ out such other 
functions as may be delegated to it by 
the NIH Director, including those 
authorities described in Section IV-C- 
l-b-42). ORDA’s responsibilities 
include, but are not limited to the 
following: 
Section IV-C-3-a. Reviewing and 
approving experiments in conjunction 
with ad hoc experts involving the 
cloning of genes encoding for toxin 
molecules that are lethal for vertebrates 
at an LDso <100 nanograms per kilogram 
body weight in organisms other than 
Escherichia coli K-12 (see Section III- 
B-1 and Appendices F-I and F-Il); 
Section IV-C-3-b. Reviewing and 
approving certain experiments 
involving the deliberate transfer of 
recombinant DNA or DNA or RjNA 
derived from recombinant DNA into one 
OT more human subjects in consultation 
with the RAC Chair and one or more 
FGAC members, as necessary, that qualify 
for the Accelerated Review process (see 
Section IlI-B-2); 
Section IV-C-3-c. Reviewing and 
approving minor changes to hun’.an 
gene transfer protocols approved under 
Sections lIl-A-2 and 151-B-2, in 
consultation with the R.AC Chair and 
one or more RAC members, as 
necessary; 
Section IV-C-3-d. Kevie'ving and 
approving the membership of an 
institution's Institutional Biosafety 
Committee, and where it finds the 
Institutional Biosafety Committee meets 
the requirements set forth in Section f\^- 
B-2 will give its approval to the 
Institutional Biosafety Committee 
membership; 
Section IV-C-3-e. Publishiirg in the 
Federal Register: 
Section IV-C-3-e-(l). 
Announcements of RAC meetings and 
agendas at least 15 days in advance 
(Note — If the agenda for a R.AC meeting 
is modified, ORDA shall make the 
revised agenda available to anyone upon 
request at least 72 hours in advance of 
the meeting); 
Section lV-C-3-e-(2). Proposed 
Major Actions to the NIH Guidelines 
(see Section IV-C-l-b-(l)) at least 15 
days prior to the R.AC meeting; 
Section IV-C-3-f. Serve as the fora I 
point for data management of N5H- 
approved human gene transfer protocols 
approved under Sections III-A-2 and 
llI-B-2 and registered with NIH/ORDA 
as required under Section lII-C-7; 
Section IV-C-3-g. Serve as the 
executive secretary of the RAC; and 
Section IV-C-3-h. Maintain a list of 
Major and Minor Actions approved 
under Section IlI-A-2 and lIl-B-3 and 
a list of experiments registered with 
NIH/ORDA as described in Section FH- 
C-7. 
E. Amendment and Addition to Section 
V, Footnotes ond References of Sections 
)-lV of the MIH Guidelines 
The amended version of Section V-U 
reeds as follows: 
Section V-U. Human studies in which 
the induction or enhancement of an 
immune response to a vector-encoded 
microbial immunogen is the major goal, 
such an immune response has been 
demonstrated in model sy stems, and the 
persi.stence of the vector-encoded 
immunogen is not expected, are not 
covered under Sections lII-A-2, IIl-B- 
2, or IIl-B-3. Such st’jdies may be 
initiated without RAC review and NIH 
approval if approved by another Federal 
agency.” 
The following new footnote, V-W is 
added to Section V; 
Section V-IV. In accordance with 
accepted scientific and regulatory 
practice.s of the discipline of pla.nt 
pathology, an exotic plant pathogen 
(e.g., vipjs, bacteria, or fungus) is one 
th.at is unknown to occur within the 
U S (see Section V-R). Deterrniriation of 
whether a pathogen has a potential for 
seriotis detrimental impact on managed 
(agricultural, forest, grassland) or 
natural ecosystems should be made by 
the Principal Investigator and the 
Institutional Biosafety Committee, in 
consultation with scientists 
knowledgeable of plant disea.ses, crops, 
and ecosystems in the geographic area 
of the research. 
F. Addition to Appendix C-I, 
Recombinant DNA in Tissue Culture., oj 
the NIH Guidelines 
The amended version of Appendix C- 
I reads as follows: 
Appendix C-I. Recombinant DNA in 
Tissue Culture 
Recombinant DNA molecules 
containing less than one-half of any 
eukaryotic viral genome (all viruses 
from 3 single family (see Appendix C- 
Vl-D) being considered identical (see 
Appendix C-Vi-E), that are propagated 
and maintained in cells in tissue culture 
are exempt from these NIH Guidelines 
w'ith the exceptions listed in Appendix 
C-I- A. 
.•^pper^d/.x C-I-A. Exceptions 
The iollowing categories are laot 
exempt from the NIH Guidelines: (») 
Experiments described in Section Ill-A 
which require specific RAC review and 
NIH and Institutional Biosafety 
Committee approval before initiation. 
(ii) experiments described in Section 
Ill-B which require NIH/ORDA and 
Institutional Biosafety Committee 
approval before initiation, (iii) 
experiments involving DNA from Class 
3, 4, or 5 organisms (see Appendix C- 
Vl-A) or ceils known to be infected with 
these agents, (iv) experiments involving 
the deliberate introduction of genes 
coding for the biosynthesis of molecules 
that are toxic for vertebrates (see 
Appendix F), and (v) whole plants 
regenerated from plant cells and tissue 
cultures are covered by the exemption 
provided they remain axenic cultures 
even though they differentiate into 
embryonic tissue and regenerate into 
plantlets. 
G. Addition to Appendix G, Physicai 
Containment, of the NJH Guidelines 
Appendix G through G-I is amended 
to read as follows: 
Appendix G specifies phy sical 
containment for standard laboratory- 
experiments and defines Biosafety I--C' » : 
Recombinant DNA Research, Volume 19 
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