Federal Register / Vol. 44, No. 232 / Friday, November 30, 1979 / Notices 
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future may be certified as HVl and HV2. 
At the time of certification, the 
classification of containment levels for 
experiments using them will be assigned 
by NIH. 
Ill— B— 2. Return of DNA Segments to 
Prokaryotic Non-HVl Host of Origin. 
Certain experiments involving those 
prokaryotes that exchange genetic 
information with E. coli by known 
physiological processes will be exempt 
from these Guidelines if they appear on 
the "list of exchangers" set forth in 
Appendix A (see Section I— E— 4). For a 
prokaryote which can exchange genetic 
information[35) with E. coli under 
laboratory conditions but which is not 
on the list (Host A), the following type of 
experiment may be carried out under Pi 
conditions without Host A having been 
approved as an HVl host: DNA from 
Host A may be inserted into a vector 
and propagated in E. coli K-12 under Pi 
conditions. Subsequently, this 
recombinant DNA may be returned to 
Host A by mobilization, transformation, 
or transduction and may then be 
propagated in Host A in any desired 
vector under Pi conditions. 
For a prokaryote which does not 
exchange genetic information with E. 
coli (Host B). the following type of 
experiment may be carried out without 
Host B having been approved as an HVl 
host: DNA from Host B may be inserted 
into a lambdoid phage vector or into a 
vector from a certified EK2 host-vector 
system and propogated in E. coli K-12 
under Pi conditions. Subsequently, this 
recombinant DNA may be returned to 
Host B and propagated in Host B under 
Pi conditions. [43] 
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-(lMb). 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. [2A] 
III— C. Experiments with Eukaryotic 
Host-Vectors. 
Ill— C— 1 . Vertebrate Host-Vector 
Systems. [44j (Summary given in Table 
IV). 
III-C-1-a. Polyoma Virus. 
Ill— C— 1— a— (1). Productive Virus-Cell 
Interactions. 
Ill— C— 1— a— (1 ) — (a). Defective or whole 
polyoma virus genomes, with 
appropriate helper, if necessary, can be 
used in P2 conditions to propagate DNA 
sequences: 
II I— C— 1 — a— ( 1 ) — ( a )— ( J ) . from bacteria of 
class 1 or class 2[1] or their phages or 
plasmids, except for those that produce 
potent polypeptide toxins;[34] 
III— C— 1— a— { 1 }— ( a )— (^) . from mice: 
III— C— 1 — a— { 1 )— ( a )— ( J) . from eukaryotic 
organisms that do not produce potent 
polypeptide toxins, [34] provided that the 
DNA segment is > 99% pure. 
IlI-C-l-a-(l)-(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. [34] 
III-C-l-a-(lMc). 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] 
III— 0—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 prescribed physcial and biological 
containment conditions. (See Section 
IV-E-l-b-(3)-(c).) 
Ill— C— 1— b. Simian Virus 40. 
Ill— C— 1— b — (1 ). Productive Virus-Cell 
Interactions. 
III-C-l-b-(lHa). 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)— (7). bacteria of Class 
1 or Class 2,[1] or their phages or 
plasmids, except for those that produce 
potent polypeptide toxins: [34] 
III-C-l-b-(l)-fa)-(2). uninfected 
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 
[ 207 ] 
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 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-(3Hc).) 
Ill— C— 1— 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 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-l-c. Human Adenoviruses 2 and 
5. 
Ill— C— 1— c— (1 ). Productive Virus-Cell 
Interactions. 
1 1 1— 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 to propagate DNA sequences 
from: 
III— C— 1— c— (1 )— (a)— (7). bacteria of Class 
1 or Class 2[1] or their phages or 
plasmids except for those that produce 
potent polypeptide toxins;[34] 
III— C— 1— c— (1)— (a)— (^). eukaryotic 
organisms that do not produce potent 
polypeptide toxins[34] (shotgun 
experiments or purified DNA). 
Ill— C— 1— c— (1)— (b). 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 
contaninment 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 
