Federal Register / Vol. 44, No. 232 / Friday, November 30, 1979 / Notices 
69219 
vertebrates require P2 + HV2 or P3 + 
HVl. Any species that has a 
demonstrated capacity for carrying 
particular pathogenic micro-organisms is 
included in this group, unless the 
organisms used as the source of DNA 
have been shown not to contain those 
agents, in which case they may be 
placed in the following group. [2A] 
III— A— 1— a— (5)— (b). The remainder of 
the species in this class including plant 
pathogenic or symbiotic fungi that do 
not produce potent toxins: P2 + HVl or 
Pi + HV2. However, any insect in this 
group must be either (i) grown under 
laboratory conditions for at least 10 
generations prior to its use as a source 
of DNA, or (ii) if caught in the wild, must 
be shown to be free of disease-causing 
micro-organisms or must belong to a 
species that does not carry micro- 
organisms causing disease in 
vertebrates or plants. [2A] If these 
conditions cannot be met. experiments 
must be done under P3 + HVl or P2 + 
HV2 containment. 
Ill— A— 1— a— (6). Plants. P2 physical 
containment + an HVl host-vector, or 
Pi + HV2. If the plant source makes a 
potent polypeptide toxin, [34] the 
containment must be raised to P3 
physical containment + an HV2 host- 
vector. When the potent toxin is not a 
polypeptide and is likely not to be the 
product of closely linked plant genes, 
containment may be reduced to P3 + 
HVl or P2 + HV2. [2A] 
III— A— 1— b. Prokaryotic DNA 
Recombinants. P2 + HVl or Pi + HV2 
for experiments with phages, plasmids 
and DNA from nonpathogenic 
prokaryotes which do not produce 
polypeptide toxins [34]. P3 + HV2 for 
experiments with phages, plasmids and 
DNA from Class 2 agents [1]. 
III-A-2-a. Viruses of Eukaryotes 
(summary given in Table III; see also 
exception given at asterisk at end of 
Appendix D). 
lII-A-2-a-( 1 H a )• Nontransforming 
viruses. 
IlI-A-2-a-(l)-(a)-(/). Adeno- 
Associated Viruses. Minute Virus of 
Mice. Mouse Adenovirus (Strain FL). 
and Plant Viruses. Pi physical 
containment + and HVl host-vector 
shall be used for DNA recombinants 
produced with (i) the whole viral 
genome, (ii) subgenomic DNA segments, 
or (iii) purified cDNA copies of viral 
mRNA. [37] 
III-A-2-a-(l)-(a)-{2). Hepatitis B. 
Ill— A— 2— a— (1 )— ( a )— (^)— { o ) . Pi physical 
containment + an HVl host-vector shall 
be used for purified subgenomic DNA 
segments. [38] 
III-A-2-a-(l)-{a)-{.2)-(i). P2 physical 
containment + an HV2 host-vector, or 
P3 + HVl, shall be used for DNA 
recombinants produced with the whole 
viral genome or with subgenomic 
segments that have not been purified to 
the extent required in footnote 38. 
III-A-2-a-{l)-(a)-(2)-(c). P2 physical 
containment + an HVl host and a 
vector certified for use in an HV2 
system, or P3 + HVl, shall be used for 
DNA recombinants derived from 
purified cDNA copies of viral mRNA. 
[37] 
III- A-2-a-( 1 )-{ a )-(.?). Other 
Nontransforming Members of Presently 
Classified Viral Families. [36] 
III-A-2-a-(l)-(a)-(J)-(a). Pi physical 
containment + an HVl host- 
subgenomic DNA[38] segments or (ii) 
purified cDNA copies of viral mRNA. 
[37] 
III— A— 2— a— (1) — (a)— (5)— (ft). Pi physical 
containment + an HVl host and a 
vector certified for use in an HV2 
system shall be used for DNA 
recombinants produced with the whole 
viral genome or with subgenomic 
segments that have not been purified to 
the extent required in footnote 38. 
Ill— A— 2— a— (1 )— (b). Tranforming 
Viruses. [37A] 
III— A— 2— a— (1)— (b)— (7). Herpes Saimiri, 
Herpes A teles, and Epstein Barr Virus. 
[39] 
III— A— 2— a— (1)— (b)— (7)— (o). Pi physical 
containment + an HVl host-vector shall 
be used for DNA recombinants 
produced with purified nontransforming 
subgenomic DNA segments. [38] 
III— A— 2— a— (1 )— (b)— ( 7 )— ( A>). P2 physical 
containment 4 - an HVl host and a 
vector certified for use in an HV2 
system, or P3 + HVl, shall be used for 
(i) DNA recombinants produced with 
purified subgenomic DNA segments 
containing an entire transforming gene 
[38] or (ii) purified cDNA copies of viral 
mRNA. [37] 
HI— A— 2— a— (1)— (b)— (7)— (c). P3 physical 
containment + an HVl host-vector, or 
P2 + HV2, shall be used for DNA 
recombinants produced with the whole 
viral genome or with subgenomic 
segments that have not been purified to 
the extent required in footnote 38. 
III-A-2-a-(l)-(b)-{2). Other 
Tranforming Members of Presently 
Classified Viral Families. [36] 
III-A-2-a-(l)-(b)-(2)-(o). Pi physical 
containment -t- an HVl host-vector shall 
be used for DNA recombinants 
produced with purified nontransforming 
subgenomic DNA segments. [38] 
III-A-2-a-(l)-(b)-(2)-(h). P2 physical 
containment + an HVl host and a 
vector certified for use in an HV2 
system, or P3 + HVl, shall be used for 
(i) DNA recombinants produced with the 
whole viral genome, (ii) subgenomic 
DNA segments containing an entire 
transforming gene, (iii) purified cDNA 
copies of viral mRNA, [37] or (iv) 
subgenomic segments that have not 
been purified to the extent required in 
footnote 38. 
III-A-2-a-(2). DNA Transcripts of 
RNA Viruses. 
Ill— A— 2— a— (2)— (a). Retroviruses. 
1 1 1— A— 2— a —(2)— (a)— (7). Gibbon Ape, 
Woolly Monkey, Feline Leukemia and 
Feline Sarcoma Viruses. [39] 
III— A— 2— a— (a)— (2)— (7)— (a). Pi physical 
containment + an HVl host-vector shall 
be used for DNA recombinants 
produced with purified nontransforming 
subgenomic DNA segments. [38] 
11 1— A— 2— a— ( 2)— ( a )— ( 7 )— ( A ) . P2 physical 
containment + an HVl host and a 
vector certified for use in an HV2 
system, or P3 + HVl, shall be used for 
DNA recombinants produced with 
purified subgenomic DNA segments [38] 
containing an entire transforming gene. 
Ill— A— 2— a— (2)— ( a )— ( 7 )— (c). P2 physical 
containment -f an HV2 host-vector, or 
P3 + HVl, shall be used for DNA 
recombinants produced with (i) the 
whole viral genome, (ii) purified cDNA 
copies of viral mRNA, [37] or (iii) 
subgenomic segments that have not 
been purified to the extent required in 
footnote 38. 
III-A-2-a-(2)-(a)-(2). Other Members 
of the Family Retroviridiae. [36] 
III-A-2-a-(2)-{a)-(2)-(a). Pi physical 
containment + an HVl host-vector shall 
be used for DNA recombinants 
produced with purified nontransforming 
subgenomic DNA segments. [38] 
III-A-2-a-(2)-(a)-(2)-(b). P2 physical 
containment -+ an HVl host and a 
vector certified for use in an HV2 
system, or P3 + HVl, shall be used for 
DNA recombinants produced with (i) 
subgenomic DNA segments containing 
an entire transforming gene, (ii) the 
whole viral genome, or (iii) purified 
cDNA copies of viral mRNA, [37] or (iv) 
subgenomic segments that have not 
been purified to the extent required in 
footnote 38. 
Ill— A— 2— a— (2)— (b). Negative Strand 
RNA Viruses. Pi physical containment 
+ and HVl host-vector shall be used for 
DNA recombinants produced with (i) 
cDNA copies of the whole genome, (ii) 
subgenomic cDNA segments, or (iii) 
purified cDNA copies of viral mRNA. 
[37] 
III-A-2-a-(2)-(c). Plus-Strand RNA 
Viruses. 
Ill— A— 2— a— (2)— (c)— (7). Types 1 and 2 
Sabin Poliovirus Vaccine Strains and 
Strain 17D (Theiler) of Yellow Fever 
Virus. Pi physical containment + and 
HVl host-vector shall be used for DNA 
recombinants produced with (i) cDNA 
copies of the whole viral genome, (ii) 
subgenomic cDNA segments, or (iii) 
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