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Federal Regiater / Vol. 46, No. 233 / Friday. December 4, 1961 / Notices 
trananission or animal inoculation 
experiments 
Yellow fever virus — wild, when used for 
transmission or animal inoculation 
experiments 
//. Classification of Oncogenic Viruses 
on the Basis of Potential Hazard (2) 
A. Low-Risk Oncogenic Viruses 
Rous Sarcoma 
SV-40 
CELO 
Ad7-SV40 
Polyoma 
Bovine papilloma 
Rat mammary tumor 
Avian Leukosis 
Murine Leukemia 
Murine Sarcoma 
Mouse mammary tumor 
Rat Leukemia 
Hamster Leukemia 
Bovine Leukemia 
Dog Sarroma 
Masun-PTixer Monkey Virus 
Marek's 
Guinea Pig Herpes 
Lacke (Frog) 
Adenovirus 
Shopc Fibroma 
Shope Papilloma 
B. Moderate-Risk Oitcogenic Viruses 
Ad2-SV40 
FeLV 
HV Saimiri 
EBV 
SSV-1 
CaLV 
HV a teles 
Yaba 
FeSV 
///. Animal Pathogens (3) 
A. Animal disease organisms which are 
forbidden entry into the United Stales by Law 
(CDC Class S agents) 
t. Foot and mouth disease virus 
B. Animal disease organisms and vectors 
which are forbidden entry into the United 
States by USDA Policy (CDC Class 5 Agents) 
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 
Coat pox virus 
Hog cholera virus 
Louping iO virus 
Lumpy skin disease virus 
Nairobi sheep disease virus 
Newcastle disease virus (Asiatic strains) 
Mycoplasma mycoides (contagious bovine 
pleuropneumonia) 
Mycoplasma agalactiae (contagious agalactia 
of sheep) 
Rickettsia ruminatium (heart water) 
Rift valley fever virus 
Rhinderpesl virus 
Sheep pox virus 
Swine vesicular disease virus 
Teschen disease virus 
Trypanosoma vivax (Nagana) 
Trypanosoma evansi 
Theileria par\-a (East Coast fever) 
Theileria annulata 
Theileria lawrencei 
Theileria bovis 
Theileria hires’ 
Vesicular exanthema virus 
Wesselsbron disease virus 
Zyonema 
Footnotes and References of Appendix B 
*A USOA permit, required for import and 
interstate commerce of pathogens, may be 
obtained from the Animal and Plant Health 
Inspection Service. USDA. Federal Building. 
Hyattsville. MD. 207S2. 
“Since the publication of the classiTication 
in 1974 |1|. the Actinomycetes have been 
reclassified os bacterial rather than fungal 
agents. 
'“All activities, including storage of 
variola and whitepox are restricted to the 
single national facility (World Health 
Organization (WHO) Collaborating Center 
for Smallpox Research, Center for Disease 
Control, in Atlanta). 
(1) Classification of Etiologic Agents on the 
Basis of Hazard. (4th Edition. July 1974). U.S. 
Department of Health. EducaUon and 
Welfare. Public Health Service. Center for 
Disease Control, Office of Biosafety. Atlanta. 
Georgia 30333. 
(2) National Cancer Institute Safety 
Standards for Research Involving Oncogenic 
Viruses. (October 1974). U.S. Department of 
Health. Education, and Welfare Publication 
No. (NIH) 75-790. 
( 3 ) U.S. Department of Agriculture. Animal 
and Plant Health Inspection Service. 
Appendix C. — Exemptions Under l-E-5 
Section I-E-5 stales that exempt from 
these Guidelines are "Other classes of 
recombinant DNA molecules, if the 
Director. NIH. with advice of the 
Recombinant DNA Advisory Committee, 
after appropriate notice and opportunity 
for public comment, finds that they do 
not present a significant risk to health or 
the environment. (See Section fV-E-1- 
b-(lH<l))- Certain classes are exempt as 
of publication of these Revised 
Guidelines." 
The following classes of experiments 
are exempt under Section 1-E^ of the 
Guidelines: 
1. Recombinant DNAs in Tissue 
Culture. Recombinant DNA molecules 
derived entirely from non-viral 
components (that is. no component is 
derived from a eukaryotic virus), that 
are propagated and maintained in cells 
in tissue culture are exempt from these 
Cuidebnes with the exceptions listed 
below. 
Exceptions. Experiments, involving 
the deliberate introduction of genes 
coding for the biosynthesis of toxins 
potent for vertebrates. (See Appendix 
G.) 
2. Experiments Involving E. coli K-12 
host-vector systems. Experiments which 
use E. coli K-12 host-vector systems, 
with the exception of those experiments 
listed below, are exempt from these 
Guidelines provided that (a) the E. coli 
host shall not contain conjugation 
proficient plasmids or generalized 
transducing phages, and (b) lambda or 
lambdoid or Ff bacteriophages or 
nonconjugative plasmids [49] shall be 
used as vectors. However, experiments 
involving the insertion into E. coli K-12 
of DNA from prokaryotes that exchange 
genetic information [35] with E. coli may 
be performed with any E. coli K-12 
vector (e.g., conjugative plasmid). When 
a nonconjugative vector is used, the E. 
coli K-12 host may contain conjugation 
proficient plasmids either autonomous 
or integrated, or generalized transducing 
phages. 
For these exempt experiments. PI 
physical containment conditions are 
recommended. 
Exceptions. Experiments involving the 
deliberate cloning of genes coding for 
the biosynthesis of toxins potent for 
vertebrates. (See Appendix G.) 
3. Experiments Involving 
Saccharomyces cerevisiae host-vector 
systems. Experiments which use 
Saccharomyces cerevisiae host-vector 
systems, with the exception of 
experiments listed below, are exempt 
from these Guidelined provided that 
laboratory strains are used. 
Fur these, exempt experiments, PI 
physical containment conditions are 
recommended. 
Exceptions. Experiments involving the 
deliberate cloning of genes coding for 
the biosynthesis of toxins potent for 
vertebrates. (See Appendix G.) 
4. Experiments Involving Bacillus 
subtilis host-vector systems. Any 
asporogenic Bacillus subtilis strain 
which does not revert to a sporeformer 
with a frequency greater than 10*’ can 
be used for cloning DNA from any 
nonprohibited source, with the 
exception of those experiments listed 
below. Indigenous Bacillus plasmids 
and phages, whose host-range does not 
include Bacillus cereus or Bacillus 
anlhracis, may be used as vectors. 
For these exempt experiments PI 
physical containment conditions are 
recommended. 
Exceptions. Experiments involving the 
deliberate cloning of genes coding for 
the biosynthesis of toxins potent for 
vertebrates. (See Appendix G.) 
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