Federal Register / Vol. 45, No. 227 / Friday, November 21, 1980 / Notices 
77395 
III— B— 3. Non-HVl Systems. 
Containment levels for other classes of 
experiments involving non-HVl systems 
may be approved by the Director, NIH. 
(See Sections IV-E-l-b-(l)-(b), IV-E-1- 
b-(2)-(c), and IV-E-l-b-(3)-(b).) 
In those cases where genetic 
exchange has not been demonstrated 
between two bacterial species A and B, 
neither of which is known to be 
pathogenic for man, animals, or plants, 
recombinant DNA experiments 
involving only A and B can be 
conducted under P3 containment.(Z4) 
Lower levels of physical containment 
may be assigned by NIH for specific 
donor-recipient combinations (See 
Section IV-E-l-b-2-(f)). 
Ill— C. Experiments with Eukaryotic 
Host- Vectors. 
Ill— C— 1. Vertebrate Host-Vector 
System. (44) The subsections of Sections 
III-C-1-a, -b, -c and -d involve the use 
of specific viral vectors, namely 
polyoma, SV40, human adenoviruese 2 
and 5, and mouse adenovirus strain FL, 
respectively. The subsections of Section 
III-C-1-e involve the use of all viral 
vectors including the specific viral 
vectors considered in the subsections of 
Sections III-C-1-a, -b, -c and -d, as 
well as any other viral vector. When the 
reader finds that the containment level 
given for specific experiment in a 
subsection of Section III-C-1-e is 
different from the containment level 
given in a subsection of Section III— C— 1— 
a, -b, -c or -d, he may choose which of 
the two containment levels he wishes to 
use for the experiment. 
III-C-1-a. Polyoma Virus. 
Ill— C— 1— a— ( 1 ) . Productive Virus-Cell 
Interactions. 
III-C-l-a-(l)-(a). Defective or whole 
polyoma virus genomes, with 
appropriate helper, if necessary, can be 
used in P2 conditions to propagate DNA 
sequences: 
III— C— 1— a— (1)— (a)— (2). from bacteria of 
Class 1 or Class 2 (7) or their phages or 
plasmids, except for those that produce 
potent polypeptide toxins; [34] 
III-C-l-a-(l)-(a)-(2). from mice; 
III-C-l-a-(l)-(a}-(5). from eukaryotic 
organisms that do not produce potent 
polypeptide toxins, ( 34 ) provided that 
the DNA segment is > 99% pure. 
Ill— C— 1— a— (1)— (b). Defective polyoma 
genomes with appropriate helper, if 
necessary, can be used in P2 conditions 
for shotgun experiments to propagate 
DNA sequences from eukaryotic 
organisms that do not produce potent 
polypeptide toxins.(<?4/ 
III-C-l-a-(l)-(C). Whole virus 
genomes with appropriate helper, if 
necessary, can be used in P3 conditions 
for shotgun experiments to propagate 
DNA sequences from eukaryotic 
organisms that do not produce potent 
polypeptide toxins. [34). 
Ill— C— 1— a— (1)— (d). Experiments 
involving the use of defective polyoma 
virus genomes to propagate DNA 
sequences from eukaryotic viruses will 
be evaluated by NIH on a case-by-case 
basis(45) and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV-E-l-b-(3)-(c).) 
Ill— C— 1— a— (2). Nonproductive Virus- 
Cell Interactions. Defective or whole 
polyoma virus genomes can be used as 
vectors in P2 conditions when 
production of viral particles cannot 
occur (e.g., transformation of 
nonpermissive cells or propagation of an 
unconditionally defective recombinant 
genome in the absence of helper), 
provided the inserted DNA sequences 
are not derived from eukaryotic viruses. 
In the latter case, such experiments will 
be evaluated by NIH on a case-by-case 
basis{45) and will be conducted under 
the precribed physical and biological 
containment conditions (See Section IV- 
E— 1— b— (3)— (c).) 
III-C-1-b. Simian Virus 40. 
Ill-C-l-b-(l). Productive Virus-Cell 
Interactions. 
Ill— C— 1— b— (1 )— ( a ) . SV40 DNA, 
rendered unconditionally defective by a 
deletion in an essential gene, with 
appropriate helper, can be used in P2 
conditions to propagate DNA sequences 
from: 
III— C— 1— b— (1)— (a)— (2). bacteria of Class 
1 or Class 2,(7) or their phages or 
plasmids, except for those that produce 
potent polypeptide toxins;(34) 
III-C-l-b-(l)-(a)-(2). unifected 
African green monkey kidney cell 
cultures. 
Ill— C— 1— b— (1)— (b). SV40 DNA, 
rendered unconditionally defective by a 
deletion in an essential gene with an 
appropriate helper, can be used in P3 
conditions to propagate DNA sequences 
from eukaryotic organisms that do not 
produce potent polypeptide toxins(34) 
(Shotgun experiments or purified DNA). 
Ill— C— 1— b— (1 )— (c). Experiments 
involving the use of defective SV40 
genomes to progagate DNA sequences 
from eukaryotic viruses will be 
evaluated by NIH on a case-by-case 
basis(45) and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV-E-l-b-(3)-(c).) 
III-C-l-b-(2). Nonproductive Virus- 
Cell Interactions. Defective or whole 
SV40 genomes can be used as vectors in 
P2 conditions when production of viral 
particles cannot occur (e.g., 
transformation of nonpermissive cells or 
propagation of an unconditionally 
defective recombinant genome in the 
absence of helper), provided the 
inserted DNS sequences are not derived 
from eukaryotic viruses. In the latter 
case, such experiments will be 
evaluated by NIH on a case-by-cdse 
basis(45) and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV-E-l-b-(3)-(c).) 
III-C-l-c. Human Adenoviruses 2 and 
5. 
Ill— C— 1— c— (1). Productive Virus-Cell 
Interactions. 
Ill— C— 1— c— (1 )— ( a ) . Human 
adenoviruses 2 and 5, rendered 
unconditionally defective by deletion of 
at least two essential genes, with 
appropriate helper, can be used in P3 
conditions t<? propagate DNA sequences 
from: 
III— C— 1— c— (1)— (a)— (2). Bacteria of Class 
1 or Class 2 (7) or their phages or 
plasmids except for those that produce 
potent ploypeptide toxins; [34). 
Ill— C— 1— c— (1)— (a)— (2). Eukaryotic 
organisms that do not produce potent 
polypeptide toxins [34) (shotgun 
experiments or purified DNA). 
III-C-l-c-(lHb). Experiments 
involving the use of unconditionally- 
defective human adenovirus 2 and 5 
genomes to propagate DNA sequences 
from eukaryotic viruses will be 
evaluated by NIH on a case-by-case 
basis [45) and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV-E-l-b-(3)-(c).) 
III-C-l-c-(2). Nonproductive Virus- 
Cell Interactions. Defective or whole 
human adenovirus 2 and 5 genomes can 
be used as vectors in P2 -conditions 
when production of viral particles 
cannot occur (e.g., transformation of 
nonpermissive cells or propagation of an 
unconditionally defective recombinant 
genome in the absence of helper), 
provided the inserted DNA sequences 
are not derived from eukaryotic viruses. 
In the latter case, such experiments will 
be evaluated by NIH on a case-by-case 
basis [45) and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV — E— 1— b— (3 )— ( c) . ) 
III-C-1-d Murine Adenovirus Strain 
FL. 
Ill— C— 1— d— (1 ) . Productive Virus-Cell 
Interactions. 
Ill— C— 1— d— (1)— (a). Unconditionally 
defective murine adenovirus strain FL 
genomes, with appropriate helper, can 
be used in P2 conditions to propagate 
DNA sequences from: 
III— C— 1— d— (1)— (a)— (7). Bacteria of 
Class 1 or Class 2 (7) or their phages or 
plasmids except for those that produce 
potent polypeptide toxins; [34). 
[ 14 ] 
