NOTICES 
33089 
(ii) consist of a defective genome, or an ap- 
propriate conditional lethal mutant virus, 
making vector and helper dependent upon 
each other for propagation. 
However, neither of these stipulations is a 
requirement. 
45. Review by NIH on a case-hy-case basis 
means prior review and the setting or appro- 
priate containment conditions by NIH. NIH 
actions in such case-by-case reviews will be 
published in the Recombinant DNA Techni- 
cal Bulletin. 
46. Provided the inserted DNA sequences 
are not derived from eukaryotic viruses. In 
the latter case, such experiments will be 
evaluated on a case-by-case basis. 
47. a 99% pure; otherwise as for shotgun 
experiments. 
Appendix A 
Section I-E-4 states that exempt 
from these Guidelines are “certain 
specified recombinant DNA molecules 
that consist entirely of DNA segments 
from different species that exchange 
DNA by known physiological process- 
es, though one or more of the seg- 
ments may be a synthetic equivalent. 
A list of such exchanges will be pre- 
pared and periodically revised by the 
Directed, NIH, on the recommendation 
of the Recombinant DNA Advisory 
Committee, after appropriate notice 
and opportunity for public comment. 
Certain classes are exempt as of publi- 
cation of these Revised Guidelines. 
The list is in Appendix A.” 
Under exemption I-E-4, as of the 
publication of these Revised Guide- 
lines, are any recombinant DNA mole- 
cules that are (1) composed entirely of 
DNA segments from one or more of 
the organisms listed below' and (2) to 
be propagated in any of the organisms 
listed below. 
Escherichia species 
Edioardsiella species 
Citrobacter species (including Le- 
vinea ) 
Salmonella species (including Arizo- 
na) 
Shigella species 
Klebsiella species 
Enterobacter species 
Hafnia species 
Serratia species 
Erwinia species (including Pectobac- 
terium) 
Pseudomonas species 
Rhizobium species 
Acinetobacter calcoaceticus 
Agrobacterium tumefaciens 
Rhodopseudomonas sphaeroides 
Appendix B 
CLASSIFICATION OF MICROORGANISMS ON 
THE BASIS OF HAZARD* 
I. Classification of Eciologic Agents on 
the Basis of Hazard (I) 
A. CLASS I AGENTS 
All bacterial, parasitic, fungal, viral, 
rickettsial, and chlamydial agents 
not included in higher classes. 
•See Part V. Footnotes and References, 
ref. 7. 
B. CLASS 2 AGENTS 
1. Bacterial agents; 
Actinobacillus — all species except A. 
mallei, which is in Class 3 
Arizona hinshawii — all serotypes 
Bacillus anthracis 
Bordetella — all species 
Borrelia recurrentis, B. vincenti 
Clostridium botulinum. Cl. chau- 
voei. Cl. haemolyticum, Cl. histoly- 
ticum, Cl. novyi, Cl. septicum. Cl. 
tetani 
Corynebacterium diphtheriae, C. 
egui, C. haemolyticum, C. pseudo- 
tuberculosis, C. pyogenes, C. renale 
Diplococcus ( Streptococcus ) pneu- 
moniae 
Erysipelolhrix insidiosa 
Escherichia coli — all enteropatho- 
genic serotypes 
Haemophilus ducreyi, H. influenzae 
Herellea vaginicola 
Klebsiella — ail species and al 1 sero- 
types 
Leptospira interrogans — all sero- 
types 
Listeria — all species 
Mima polymorpha 
Moraxella — all species 
Mycobacteria— a\\ species except 
those listed in Class 3 
Mycoplasm.a — all species except My- 
coplasma mycoides and Myco- 
plasma agalactiae, which are in 
Class 5 
Neisseria gonorrhoeae, N. meningiti- 
dis 
Pasteurella — all species except those 
listed in Class 3 
Salmonella — all species and all sero- 
types 
Shigella — all species and all sero- 
types 
Sphaerophorus necrophorus 
Staphylococcus aureus 
Strep tobacilus moniliformis 
Streptococcus pyogenes 
Treponema carateum, T. pallidum, 
and T. pertenue 
Bibrio fetus, V. comma, including 
biotype El Tor, and V. parahemoly- 
ticus 
2. Fungal agents; 
Actinomycetes (including Nocardia 
species and Actinomyces species 
and Arachnia propionica) 
Blastomyces dermatitidis 
Cryptococcus neoformans 
Paracoccidioides brasiliensis 
3. Parasitic agents: 
Endamoeba histolytica 
Leishmania sp. 
Naegleria gruberi 
Toxoplasma gondii 
Toxocara canis 
Trichinella spiralis 
Trypanosoma cruzi 
4. Viral, Rickettsial, and Chlamydial 
agents; 
Adenoviruses— human— all types 
Cache Valley virus 
Coxsackie A and B viruses 
Cytomegaloviruses 
Echoviruses—a.11 types 
Encephalomyocarditis virus (EMC) 
Flanders virus 
Hart Park virus 
Hepatitis-associated antigen materi- 
al 
Herpes viruses — except Herpesvirus 
simiae (Monkey B virus) which is 
in Class 4 
Corona virus 
Influenza viruses — all types except 
A/PR8/34, which is in Class 1 
Langet virus 
Lymphogranuloma venereum agent 
Measles virus 
Mumps virus 
Parainfluenza turns— all types 
except Parainfluenza virus 3, SF4 
strain, which is in Class 1 
Polioviruses — all types, wild and at- 
tenuated 
Poxviruses — all types except Al.as- 
trim, Smallpox, Monkey pox, and 
Whitepox , which, depending on ex- 
periments. are in Class 3 or Class 4 
Rabies virus — all strains except 
Rabies street virus, which should 
be classified in Class 3 when inocu- 
lated into carnivores 
Reoviruses — all types 
Respiratory syncytial virus 
Rhinoviruscs — all types 
Rubella virus 
Simian viruses— all types except 
Herpesvirus simiae ( Monkey B 
virus) and Marburg virus, which 
are in Class 4 
Sindbis virus 
Tenscw virus 
Turlock virus 
Vaccinia virus 
Varicella virus 
Vole rickettsia 
Yellow fever virus, 17D vaccine 
strain 
C. CLASS 3 AGENTS 
1. Bacterial agents: 
Actinobacillus mallei* 
Eartonello. i — all species 
Burcella — all species 
Francisella tularensis 
Mycobacterium avium, M. bonis, M. 
tuberculosis 
Pasteurella multocide type B (“buf- 
falo” and other foreign virulent 
strains*) 
Pseudomonas pseudcmallei * 
Yersenia pestis 
2. Fungal agents: 
Coccidioides immitis 
Histoplasma capsulatvm 
Histoplasma capsulaium var. duboi- 
sii 
3. Parasitic agents: 
Schistosoma mansoni 
4. Viral, Rickettsial, and Chlamydial 
agents: 
Alastrim, Smallpox, Monkey pox, 
and Whitepox, when used in vitro 
Arboviruses — all strains except those 
in Class 2 and 4 (Arboviruses indig- 
*USDA permit also required for import or 
interstate transport. 
FEDERAL REGISTER, VOL. 43, NO. 146— FRIDAY, JULY 28, 1978 
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