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Federal Register / Vol. 49, No. 227 / Friday, November 23, 1984 / Notices 
Appendix B-1I-A. Low-Risk 
Oncogenic Viruses. 
Rous sarcoma 
SV-tO 
CELO 
AD7-SV40 
Polyoma 
Bovine papilloma 
Rat mammary tumor 
Avian leukosis 
Murine sarcoma 
Mouse mammary tumor 
Rat leukemia 
Hamster leukemia 
Bovine leukemia 
Dog sarcoma 
Mason-Pfizer monkey virus 
Marek's 
Guinea pig herpes 
Lucke (Frog) 
Adenovirus 
Shope fibroma 
Shope papilloma 
Appendix B-II-B. Moderate-Risk 
Oncogenic Viruses. 
Ad2-SV40 
FeLV 
HV Saimiri 
EBV 
SSV-1 
GaLV 
HV ateles 
Yaba 
FeSV 
Appendix B-III. Class 5 Agents. 
Appendix B-Ill-A. Animal Disease 
Organisms Which are Forbidden Entry 
into the United States by Law. 
Foot and mouth disease virus. 
Appendix B-III-B. Animal Disease 
Organisms and Vectors Which are 
Forbidden Entry into the United States 
by USDA 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 
Louping ill 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 
Rhinderpest virus 
Sheep pox virus 
Swine vesicular disease virus 
Teschen disease virus 
Trypanosoma vivax (Nagana) 
Trypanosoma evansi 
Theileria parva (East Coast fever) 
Theileria annulata 
Theileria latvrencei 
Theileria bo vis 
Theileria hirci 
Vesicular exanthema virus 
Wesselsbron disease virus 
Zyonema 
Appendix B-I1I-C. Organisms Which 
may not be Studied in the United States 
Except at Specified Facilities. 
Small pox (4] 
Alastrim (4] 
White pox [4] 
Appendix B-IV — Footnotes and References 
of Appendix B 
(7) The original reference for this 
classification was the publication 
Classification of Etiologic 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. For the purposes of these 
Guidelines, this list has been revised by the 
NIH. 
(2) Since the publication of the 
classification in 1974(7), the Actinomyceles 
have been reclassified as bacterial rather 
than fungal agents. 
(3) 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. 
(4) 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], 
(5) 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. 
(6) U.S. Department of Agriculture, Animal, 
and Plant Health Inspection Service. 
Appendix C — Exemptions Under 
Section III-D-5 
Section III-D-5 states that exempt 
from these Guidelines are "Other 
classes of recombinant DNA molecules 
if the Director, NIH, with advice of the 
RAC, after appropriate notice and 
opportunity for public comment finds 
that they do not present a significant 
risk to health or the environment (see 
Section IV— C— 1— b— (1) — (c)). Certain 
classes are exempt as of publication of 
these revised Guidelines.” 
The following classes of experiments 
are exempt under Section III-D-5 of the 
Guidelines: 
Appendix C-I. 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 
Guidelines with the exceptions listed 
below. 
Exceptions. 
Experiments described in Section III— 
A which require specific RAC review 
and NIH approval before initiation of 
the experiment. 
Experiments involving DNA from 
Class 3, 4. or 5 organisms(7) or cells 
known to be infected with these agents. 
Experiments involving the deliberate 
introduction of genes coding for the 
biosynthesis of molecules toxic for 
vertebrates (see Appendix F). 
Appendix C-I I. 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: (i) the E. coli host shall not contain 
conjugation proficient plasmids or 
generalized transducing phages, and (ii) 
lambda or lambdoid or Ff 
bacteriophages or nonconjugative 
plasmids(2) shall be used as vectors. 
However, experiments involving the 
insertion into E. coli K-12 of DNA from 
prokaryotes that exchange genetic 
information^) 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 laboratory 
experiments, BLl physical containment 
conditions are- recommended. 
For large-scale (LS) fermentation 
experiments BLl-LS physicial 
containment conditions are 
recommended. However, following 
review by the IBC of appropriate data 
for a partcular host-vector systemn, 
some latitude in the application of BLl- 
LS requirements as outlined in 
Appendix K-II-A through K-II-F is 
permitted. 
Exceptions. 
Experiments described in Section III— 
A which require specific RAC review 
and NIH approval before initiation of 
the experiment. 
Experiments involving DNA from 
Class 3, 4, or 5 organisms(7) or from cells 
known to be infected with these agents 
may be conducted under containment 
conditions specified in Section III— B— 2 
with prior IBC review and approval. 
Large-scale experiments (e.g., more 
than 10 liters of culture) require prior 
IBC review and approval (see Section 
III— B — 5). 
Experiments involving the deliberate 
cloning of genes coding for the 
biosynthesis of molecules toxic for 
vertegrates (see Appendix F). 
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