Federal Register Vol. 45, No. 73, / Monday, April 14, 1980 / Notices 
25367 
A gene of Pseudomonas aeruginosa in E. coli 
K-12 is permitted. Under exemption I-E-4, P. 
aeruginosa and genus Escherichia are listed 
in Appendix A, Sublist A. 
However, according to Section I-E, 
Exemptions: 
It must be emphasized that the following 
exemptions (4) are not meant to apply to 
experiments described in the Sections I-D-l 
to I-D-5 as being prohibited. 
Section l-D-2 prohibits: 
Deliberate formation of recombinant 
DNA’s containing genes for the biosynthesis 
of toxins potent for vertebrates (2A) (e.g., 
botulinum, diphtheria toxins; venoms from 
insects, snakes, etc). 
Dr. Shuster notes that exotoxin A and P. 
aeruginosa are safe under normal laboratory 
conditions. P. aeruginosa is an opportunistic 
pathogen and exotoxin A is only one of a 
series of virulence factors necessary to 
\ produce pathogenicity. This request was 
presented to the RAC at its December 6-7, 
1979 meeting. At that time, the RAC felt that 
approval of the proposed experiments 
appeared to require an exception to a 
prohibition. Accordingly, the request is being 
published in the Federal Register for a thirty 
day comment period prior to being 
reconsidered by the RAC at its March ft-7, 
1980 meeting." 
Prior to the March 8-7, 1980 RAC 
meeting, two additional requests for 
permission to perform similar 
experiments were received. 
Dr. Stanley Falkow of the University 
of Washington requested permission to 
clone the exotoxin A gene. His long 
letter of January 18, 1980 included die 
following arguments: (1) Pseudomonas 
aeruginosa is ubiquitous in nature. (2) 
Pseudomonas aeruginosa does not 
ordinarily cause disease in healthy 
individuals. It is a CDC Class 1 agent. (3J 
Exotoxin A is only one factor in the 
virulence of Pseudomonas aeruginosa. 
(4) Pseudomonas aeruginosa exotoxin A 
is far less toxic (1 mg. = 5 X 10 s mouse 
LD50 doses) than toxins such as 
Clostridium botulinum a toxic (1 mg. = 
1.8 X 10 8 mouse LD50 doses). 
Dr. James Miller of the University of 
Louisville, Kentucky, in a letter of 
January 18, 1980, requested permission 
to clone the Pseudomonas aeruginosa 
exotoxin A gene in Pseudomonas 
aeruginosa. 
The RAC at its March 6-7, 1980 
meeting once again considered this item. 
The importance of such experiments for 
understanding bacterial pathogenicity 
was stressed. It was agreed that 
Pseudomonas aeruginosa exotoxin A is 
not as potent a toxin as botulinum or 
diphtheria toxin. A motion that 
Pseudomonas aeruginosa exotoxin A 
not be considered a potent toxin, and 
therefore not be covered under 
Prohibition I-D-2 passed by a vote of 
seven in favor, two opposed and ten 
abstentions. Following the vote it was 
pointed out that: (a) This would allow 
total exemption from the Guidelines 
under Sections I-E-3 and I-E-4 
respectively for the cloning of the 
Pseudomonas aeruginosa exotoxin A 
gene in Pseudomonas aeruginosa and 
Escherchia coli; and (b) this was more 
than any of the investigators were 
actually requesting. A motion to 
reconsider the previous vote passed by 
a vote of Fifteen in favor, non opposed 
and two abstentions. A motion to permit 
the cloning of Pseudomonas aeruginosa 
exotoxin A in E. coli K-12 at PI + EKl 
containment passed by a vote of 
fourteen in favor, non oppossed, and 
three abstentions. 
I-E. Classification of Plant Pathogens 
The following notice appeared in the 
Federal Register of January 31, 1980: 
“In response to the proposed revised 
Guidelines for Research Involving 
Recombinant DNA Molecules published in 
the Federal Register on November 30, 1979 
(44 FR 69210), M.T. Goff, Animal and Plant 
Health Inspection Service, United States 
Department of Agriculture, has proposed that 
a classification of plant pathogens be 
included in the Guidelines. Philip D. 
Harriman, National Science Foundation, has 
also submitted a similar proposal. Messrs. 
Goff and Harriman request that a portion of 
the Report of a Workshop on Risk 
Assessment of Agricultural Pathogens, 
dealing with a hazard classification of plant 
pathogens, be included in the Guidelines. 
This Workshop was held on March 20-21, 
1978, and the report appeared as Appendix G 
to the Environmental Impact Assessment 
which accompanied proposed revised 
Guidelines published for comment in the 
Federal Register of July 28, 1978 (43 FR 33042). 
Specifically, they request that the following 
classification be added to Appendix B of the 
Guidelines: 
IV. Plant Pathogens. 
Class 1A Agents — Plant pathogens not in 
Class IB. 
Class 1A Agents — All organisms that are 
subject to quarantine restrictions for any of 
the following reasons: 
(i) Plant pathogens not known to occur in 
the United States. 
(ii) Plant pathogens that are not widely 
distributed throughout the ecological range of 
their hosts in the United States. 
’ (iii) Plant pathogens subject to U.S. Federal 
or State eradication or suppression programs. 
A USDA permit 2 is required to import or to 
move plant pathogens across State lines. 
Footnotes 2 of Appendix B of the 
proposed revised Guidelines reeds as 
follows: 
USDA permit also required for import and 
interstate transport. 
It is proposed that this footnote be 
modified to read as follows in order to 
serve as a single footnote for both 
animal and plant pathogens: 
*A USDA permit, required for import and 
interstate transport of pathogens, may be obtained 
from the Animal and Plant Health Inspection 
Service, USDA Federal Building, Hyattsville. MD 
20782. 
During the thirty day comment period, 
no comments were received. 
The RAC discussed this item at its 
March 6-7, 1980 meeting, and 
determined that the addition of the 
proposed classification of plant 
pathogens to Appendix B of the 
Guidelines was unnecessary. Rather, the 
RAC suggested by a vote of twenty in 
favor, none opposed, and no 
abstentions, that the footnote 
A USDA permit, required for import and 
interstate transport of pathogens, may be 
obtained from the Animal and Plant Health 
Inspection Service, USDA, Federal Building, 
Hyattsville, MD 20782.” 
be added to Section V of the Guidelines 
and cited wherever the Guidelines refer 
to plant pathogens. 
I accept this recommendation. 
1-F. Request for Consideration of 
Appropriate Containment Conditions 
The following notice was published in 
the Federal Register of January 31, 1980: 
"Dr. Olen Yoder of Cornell University has 
asked the RAC to consider the appropriate 
containment level for the return of 
Helminthoaporanium maydis DNA, which 
has been cloned in Saccharomyces 
cerevisiae, to the host of origin." 
During the thirty day comment period, 
no comments were received. 
The RAC at its March 6-7, 1980 
meeting discussed this proposal. 
Helminthosporanium maydis is a fungus 
which grows on com. Work will be done 
with the strain called race O. The vector 
will be the hybrid E. coli- yeast plasmid 
Ylp5. This is a “return to host of origin'’ 
type experiment with the intermediate 
host being yeast strain SHY2. The RAC 
by a vote of eight in favor, none opposed 
and nine abstentions accepted a P2 level 
of containment for the proposed 
experiments. 
I accept this recommedation. 
I-G. Request for Consideration of 
Appropriate Containment Conditions 
In response to a request of December 
13, 1979 to set containment conditions 
for experiments involving 
Schizophyllum commune, the following 
notice was placed in the Federal 
Register of January 31, 1980: 
“Dr. Marvin Schwalb of New Jersey 
Medical School has requested that the RAC 
consider the containment levels appropriate 
to the return of Schizophyllum commune 
DNA cloned in Saccharomyces cerevisiae to 
Schizophyllum commune. In addition. Dr. 
Schwalb requests permission to clone the S. 
cerevisiae derived vector YR414/ura 3 and 
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