Federal Register Vol. 45, No. 73, / Monday, April 14, 1980 / Notices 
25369 
thirteen in favor, five opposed and one 
abstention. 
During the discussion it was also 
suggested that in Section III— C— 1— e— (1)— 
(a), after the word "Family,” reference to 
footnote 36 be added, and that footnote 
36 be revised to make reference to the 
third report of the International 
Committee on Taxonomy of Viruses. 
I accept the recommendations of the • 
RAC, i.e., Footnote 36 will be revised 
and new Sections III-C-1-e, III-C-1-e- 
(1), and III— C— 1— e— (1)— (a) as 
recommended by the RAC at their 
March 6-7, 1980 meeting will replace the 
previous Sections so numbered. Sections 
III— C— 1— e— (1)— (b) and III-C-l-e-(2) 
remain identical in wording (Federal 
Register, January 29, 1980), but they now 
fall under a new heading III-C-1-e. “All 
Viral Vectors,” rather than as previously 
III-C-1-e. “All Other Potential Viral 
Vectors.” 
In addition for clarification, I am 
adding reference to a new footnote 50 in 
Section III-C-l-e-(lHa) after the words 
“ * * * considered identical).” Footnote 
50 will read “i.e. the total of all genomes 
within a Family shall not exceed two- 
thirds of the genome." 
II. Summary of Major Actions Under 
Guidelines 
11-A. Amendment of Section 111-0 of the 
Guidelines and New Footnote 49 
A new footnote 49 is added to section 
V of the Guidelines, as follows: 
" * 9 A subset of non-conjugative plasmid vectors 
are also poorly mobilizable (e.g., pBR322, pBR313). 
Where practical, these vectors should be 
emjjloyed." 
The fourth paragraph of Section III— O 
of the Guidelines is modified to add 
reference to Footnote 49, as follows: 
“Other experiments using E. coli K-12 shall 
use Pi physical containment and, except as 
specified in the last paragraph of this section, 
an EK1 host-vector system [i.e., (a) the host 
shall not contain conjugation-proficient 
plasmids or generalized transducing phages, 
and (b) lambda or lambdoid bacteriophages 
or non-conjugative plasmid* (49) shall be 
used as vectors). For these experiments 
II-B. Amendment of Section 111-0 of the 
Guidelines 
Section III-O (fourth paragraph last 
sentence) of the Guidelines is amended 
to change the words “* * * h^ve the £. 
coli K-12 efficiently express any gene 
coding for a eukaryotic protein.” to 
“* * * have the E. coli K-12 efficiently 
express as a protein product the 
information carried in any gene derived 
either from a eukaryotic organism or 
from any virus or viroid which infects a 
eukaryotic organism.” 
II-C. Inclusion of Genus Erwinia in 
Appendix A, Sublist A 
The entry "Erwinia amylovora" in 
Appendix A, Sublist A of the Guidelines 
is changed to "Genus Erwinia." 
II-D. Approval to Clone Exo toxin Gene 
of Pseudomonas Aeruginosa 
Added to Appendix E of the 
Guidelines is the following: "Permission 
is granted to clone the Exotoxin A gene 
of Pseudomonas aeruginosa under Pi + 
EKl conditions in Escherchia coli K-12 
and under Pi conditions in 
Pseudomonas aeruginosa." 
II-E. New Footnote 48 Concerning Plant 
Pathogens 
A new footnote 48 is added to Section 
V of the Guidelines, as follows: 
“‘•A USDA permit, required tor import and 
interstate transport of pathogens, may be obtained 
from the Animal and Plant Health Inspection Service, 
USDA, Federal Building, Hyattsville, MD 20782." 
Reference to footnote 48 is added as 
given below to the following sections of 
the Guidelines: 
“I-D-3. Deliberate creation by the use of 
recombinant DNA of a plant pathogen (48) 
with increased virulence and host range 
beyond that which occurs by natural genetic 
exchange (2A).” 
‘ 1 III— A— 2— a— (1 )— ( a )— ( 7) . Adeno-Associated 
Viruses, Minute Virus of Mice, Mouse 
Adenovirus (Strain FL) and Plant Viruses (48) 
* * *11 
"III— A— 2— a— (2)— (e). RNA Plant Viruses and 
Plant Viroids (48) * * *” 
"III-C-4. Plant Host-Vector Systems Other 
than Viruses (48) * * *” 
In addition the footnote given at the 
bottom of the first column of pg. 6748 of 
the Guidelines (Federal Register, 
January 29, 1980) is changed to: 
“A USDA permit, required for import and 
interstate commerce of pathogens, may be 
obtained from the Animal and Plant Health 
Inspection Service, USDA, Federal Building, 
Hyattsville, MD. 20782.” 
II-F. Return of Helminthosporanium 
Maydis DNA to Helminthosporanium 
Maydis 
Added to Appendix E of the 
Guidelines is the following: 
“Permission is granted to return to the host 
of origin Helminthosporaniuni maydis (race 
O) DNA which has been cloned in yeast 
strain SHY2 using the hybird E. coli — yeast 
plasmid Ylp5. The cloned DNA may be 
returned, to and propagated in, 
Helminthosporanium maydis at the P2 level 
of physical containment.” 
II-G. Return of Schizophyllum 
Commune and Saccharomyces 
Cere vis iae DNA to Schizophyllum 
Commune 
Added to Appendix E of the 
Guidelines is the following: 
"Permission is granted to return 
Schizophyllum commune DNA (or yeast 
DNA) cloned in Saccharomyces cerevisiae 
with YR or 2 mu circle vectors to 
Schizophyllum commune. The cloned DNA 
may be returned to. and propagated in, 
Schizophyllum commune at the P2 level of 
physical containment." 
U-H Return of Wangiella Dermatitidis 
DNA to Wangiella Dermatitidis 
Added to Appendix E of the 
Guidelines is the following: 
"Permission is granted to return Wangiella 
dermatitidis DNA to Wangiella dermatitidis ! 
using an HV2 certified Sacchromyces/E. coli • j 
hybrid vector. The Wangiella dermatitidis 
may be propagated at the P3 level of physical 
containment." 
; 
//-/. Streptococcus Mutans and 
Streptococcus Sanguis as a New Sublist I 
in Appendix A 
A neiy sublist is added to Appendix A : 
of the Guidelines as follows: 
"Sublist E — One way transfer of 
Streptococcus mutans DNA into 
Streptococcus sanguis. " 
II- J. Revision of Guidelines Section III- 
C-l-e and Its Subsections 
Revision of Footnote 36. Addition of 
New Footnote 50. A new footnote 
number 50 is added to Section V of the ! 
Guidelines as follows: 
““i.e. the total of all genomes within a Family 
shall not exceed two-thirds of the genome." 
Footnote 36 of Section V of the 
Guidelines is revised by changing the 
first sentence to: 
“As classified in the Third Report of 
International Committee on Taxonomy of viruses: 
Classification and Nomenclature of Viruses, R. E. 
F. Matthews, Ed. Intervirology 12 (129-296) 1979." I | 
Section III— C— 1— e, III— G— 1— e— (1) and 
III— C— 1— e— (1)— (a) of the Guidelines are 
revised as follows: 
“III-C-1-e, All Viral Vectors. 
Ill— C— 1— e— (1). Other experiments involving 
eukaryotic virus vectors can be done as 
follows: 
III— C— 1— e— (l)(a). Recombinant DNA 
molecules containing no more than two-thirds 
of the genome of any eukaryotic virus [all 
viruses from a single Family (36) being 
considered identical (50)) may be propagated 
and maintained in cells in tissue culture using 
PI containment. For such experiments, it 
must be shown that the cells lack helper virus 
for the specific Families of defective viruses 
being used. The DNA may contain fragments 
of the genomes of viruses from more than one 
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