Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 /-Notices 
34511 
Appendix B-V-B. Animal Disease 
Organisms and Vectors which are 
Forbidden Entry into the United States 
by U.S. Department of Agriculture 
Policy 
African horse sickness virus 
African swine fever virus 
Besnoitia besnoiti 
Boma disease virus 
Bovine infectious petechial fever 
Camel pox virus 
Ephemeral fever virus 
Fowl plague virus 
Goat pox virus 
Hog cholera virus 
Looping ill virus 
Lumpy skin disease virus 
Mycoplasma mycoides — contagious 
bovine pleuropneumonia 
Mycoplasma agalactiae — contagious 
agalactia of sheep 
Nairobi sheep disease virus 
Newcastle disease virus — Asiatic strains 
Rhinderpest virus 
Rickettsia ruminatium — heart water 
Rift valley fever virus 
Sheep pox virus 
Swine vesicular disease virus 
Teschen disease virus 
Theileria annulata 
Theileria bovis 
Theileria hirci 
Theileria lawrencei 
Theileria parva — East Coast fever 
Trypanosoma evansi 
Trypanosoma vivax — Nagana 
V'esicular exanthema virus 
VVesselsbron disease virus 
Zyonema 
Appendix B-V-C. Organisms which may 
not be Studied in the United States 
Except at Specified Facilities 
Alastrim (see Appendix B-VT-D) 
Small pox (see Appendix B-VI-D) 
White pox (see Appendix B-VI-D) 
Appendix B-VI. Footnotes and 
References of Appendix B 
Appendix B-VI-A. Tlie original 
reference for this classification was the 
publication Classification of Etiologic 
Agents on the Basis of Hazard, 4th 
edition, July 1974, U.S. DHHS, Public 
Health ^rvice. Centers for Disease 
Control and Prevention, Office of 
Biosafety, Atlanta, Georgia 30333. For 
the purposes of these NIH Guidelines, 
this list has been revised by the NIH. 
Appendix B-VI-B. A U.S. Department 
of Agriculture permit, required for 
import and interstate transport of 
pathogens, may be obtained from the 
U.S. Department of Agriculture, ATTN; 
Animal and Plant Health Inspection 
Ser\'ice, Import-Export Products Office, 
Room 756, Federal Building, 6505 
Belcrest Road, Hyattsville, Maryland 
20782 
Appendix B-VI-C. National Cancer 
Institute Safety Standards for Research 
Involving Oncogenic Viruses, U.S. 
Department of Health, Education, and 
Welfare Publication No. (NIH) 75-790, 
October 1974. 
Appendix B-VI-D. All activities, 
including storage of variola and 
whitepox, are restricted to the single 
national facility (World Health 
Organization Collaborating Center for 
Smallpox Research, Centers for Disease 
Control and Prevention, Atlanta, 
Georgia). 
Appendix B-Vl-E. U.S. Department of 
Agriculture, Animal and Plant Health 
Inspection Service. 
Appendix C Exemptions Under Section 
III-E-6 
Section III-E-6 states that exempt 
from these NIH Guidelines are “those 
that do not present a significant risk to 
health or the environment (see Section 
rV-C-l-b-(l)-(c)), as determined by the 
NIH Director, with the advice of the 
RAC, and following appropriate notice 
and opportunity for public comment. 
See Appendix C for other classes of 
experiments which are exempt from the 
NIH Guidelines.” The following classes 
of experiments are exempt under 
Section III-E-6: 
Appendix C-I. Recombinant DNA in 
Tissue Culture 
Recombinant DNA molecules 
containir^ less than one-half of any 
eukaryotic viral genome (all viruses 
from a single family (see Appendix G- 
VI-D) being considered identical (see 
Appendix C-VI-E), that are propagated 
and maintained in cells in tissue culture 
are exempt from these NIH GuideUnes 
with the exceptions listed in Appendix 
C-I- A. 
Appendix C-I- A. Exceptions 
The following categories are not 
exempt from the NIH Guidelines; (i) 
experiments described in Section III-A 
which require specific RAC review and 
NIH and Institutional Biosafety 
Committee approval before initiation, 
(ii) experiments described in Section 
III-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- 
VI-A) or cells 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. 
Appendix C-II. Escherichia coli K-12 
Host-Vector Systems 
Experiments which use Escherichia 
coli K-12 host-vector systems, with the 
exception of those experiments listed in 
Appendix C-II-A, are exempt from the 
NIH Guidelines provided that: (i) the 
Escherichia coli host does not contain 
conjugation proficient plasmids or 
generalized transducing phages; or (ii) 
lambda or lambdoid or Ff 
bacteriophages or non-conjugative 
plasmids (see Appendix C-VI-B) shall 
be used as vectors. However, 
experiments involving the insertion into 
Escherichia coli K-12 of DNA from 
prokaryotes that exchange genetic 
information (see Appendix C-VI-C) 
with Escherichia coU may be performed 
with any Escherichia coli K-12 vector 
(e.g., conjugative plasmid). When a non- 
conjugative vector is used, the 
Escherichia coli K-12 host may contain 
conjugation-proficient plasmids either 
autonomous or integrated, or 
generalized transducing phages. For 
these exempt laboratory experiments. 
Biosafety Level (BL) 1 physical 
containment conditions are 
recommended. For large scale 
fermentation experiments, the 
appropriate physical containment 
conditions need be no greater than those 
for the host organism unmodified by 
recombinant DNA techniques: tlie 
Institutional Biosafety Committee can 
specify higher containment if deemed 
necessary. 
Appendix C-II-A. Exceptions 
The following categories of 
experiments are not exempt from the 
NIH Guidelines: (i) experiments 
described in Section III-A which 
require Institutional Biosafety 
Gommittee approval, RAC review, and 
NIH approval before initiation, (ii) 
experiments described in Section III-B 
which require Institutional Biosafety 
Committee and NIH/ORDA approval 
before initiation, (iii) experiments 
involving DNA from Class 3, 4, or 5 
organisms (see Appendix C-VI-A) or 
cells known to be infected with these 
agents may bo conducted under 
containment conditions specified in 
Section III-C-2 with prior Institutional 
Biosafety Committee review and 
approval, (iv) large scale experiments 
(e.g., more than 10 liters of culture), and 
(v) experiments involving the cloning of 
toxin molecule genes coding for the 
biosynthesis of molecules toxic for 
vertebrates (see Appendix F). 
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