Federal Register / Vol. 45, No. 227 / Friday, November 21, 1980 / Notices 
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reviewer said the working group was 
satisfied with the data presented, and 
said the single issue not addressed by 
Dr. Burke concerned the possibility of 
transfer of genetic information from 
ASB298 to other Bacilli by 
transformation. After some discussion of 
this point, the RAC deferred 
consideration of the proposal pending 
the submission of additional information 
on transformation frequencies in soil. 
In an addendum dated September 8, 
1980, Dr. Burke supplied information on 
the persistence of ASB298 in sterile soil, 
and on the frequency of genetic 
exchange in both soil and under 
optimized laboratory conditions 
between strain ASB298 and highly 
transformable B. subtilis strains. 
A second notice concerning Dr. 
Burke’s request subsequently appeared 
in the Federal Register of August 21, 
1980 (45 FR 55925). No comments on this 
request were received by the NIH. 
The RAC reconsidered this request at 
its September 25-26, 1980 meeting. On 
the basis of the strain’s characteristics 
and the frequency of transformation in 
soil, the RAC recommended, by a vote 
of 14 in favor, none opposed, and 2 
abstentions, that strain ASB298 be 
certified as the host component of a B. 
subtilis HV2 host-vector system. The 
RAC specified that ASB898 be used with 
plasmids certified as the vector 
components of HVl Bacillus subtilis 
host-vector systems. 
I accept this recommendation, and 
text has been added to Appendix D of 
the Guidelines indicating this. 
IV. Proposed Amendments Of Section 
IV-E-2. 
In a letter dated April 10, 1980, Dr. 
Irving Johnson of Eli Lilly and Company, 
submitted several proposals to amend 
the Guidelines. One of these proposals 
would have amended Section IV-E-2 to 
include the following language: 
“Appropriate representatives of 
industry shall also be chosen to provide 
expertise in fermentation technology, 
engineering, and other aspects of large- 
scale production." 
This proposal appeared in the Federal 
Register of April 30, 1980 (45 FR 28908). 
Two comments were received during the 
thirty day comment period. One 
commentator slated that: 
“Any attempt to add industrial expertise to 
the committee * * * is to convert the 
committee to a self-appointed consensus 
standards organization." 
Another commentator said, "We 
strongly object to (this) proposal * * *” 
The RAC considered this proposal at 
the June 5-6, 1980 meeting. The 
committee agreed that, while it would 
be desirable to have a member with 
expertise in fermentation technology 
appointed to RAC, language specifying 
“representatives of industry” was 
inappropriate. The RAC agreed that the 
following amended language should be 
published for comment and considered 
at the September 1980 meeting: 
“Members should be chosen to provide 
expertise in fermentation technology, 
engineering, and other aspects of large-scale 
production.” 
In a letter dated July 25, 1980, Dr. 
Johnson requested that his original 
language amending Section IV-E-2 be 
reconsidered at the September 1980 
meeting. Dr. Johnson’s proposed 
language and the language constructed 
by the RAC both appeared for public 
comment in the Federal Register of 
August 21, 1980 (45 FR 55928). One 
comment was received during the thirty 
day comment period: 
“We have long held the view that the RAC 
membership should include persons versed in 
scientific aspects of industrial microbiology. 
As with the rest of the Committee, they 
should be selected for the excellence of their 
qualifications. Such persons would 
complement the present technical expertise 
of RAC by providing knowledge in areas of 
fermentation technology and large-scale 
industrial applications. This expertise differs 
from that of safety engineers and is 
concerned with basic biological problems of 
large-scale technology * * *” 
The proposals to amend the language 
of Section IV-E-2 were discussed by the 
RAC at the September 25-26, 1980 
meeting. At that time, the RAC again felt 
that appointing fermentation technology 
expertise to RAC was desirable, but that 
the proposal language specifying 
appointment of “representatives of 
industry” was inappropriate. By a vote 
of 13 in favor, 2 opposed, and 2 
absentions, the RAC recommended 
approval of the following language: 
“Members should be chosen to provide 
expertise in fermentation technology, 
engineering, and other aspects of large-scale 
production.” 
I accept the intent of the RAC 
recommendation that RAC “members 
should be chosen to provide expertise in 
fermentation technology, engineering, 
and other aspects of large-scale 
production.” I do not believe that it is 
necessary to change the NIH Guidelines 
or the RAC Charter in order to assure 
that the intent of the RAC be honored. 
This can be accomplished through 
appointment of one or more individuals 
with appropriate expertise to fill 
vacancies that periodically occur in 
RAC membership. 
V. Request to Clone 
Schizosaccharomyces Pombe DNA in 
Schizosaccharomyces Pombe Using 
Hybrid Plasmid Vectors 
Dr. Benjamin Hall of the University of 
Washington requested permission to 
clone Schizosaccharomyces pombe 
DNA in Schizosaccharomyces pombe 
using approved HVl Saccharomyces 
cerevisiae/E. coli hybrid plasmids as 
vectors. Dr. Hall pointed out that 
Schizosaccharomyces pombe has been 
the subject of intense genetic studies in 
the laboratory and has been used to 
ferment beverages for human 
consumption. He requested that PI be 
established as the level of physical 
containment. 
This proposal appeared in the August 
21, 1980, Federal Register (45 FR 55929). 
No comments were received during the 
thirty day comment period. 
The RAC discussed this proposal at 
its September 25-26, 1980 meeting, and 
recommended approval by a vote of 17 
in favor, none opposed. 
I accept this recommendation, and 
text has been added to Appendix E of 
the Guidelines indicating this. 
VI. Proposed Amendment of Appendix 
E of the Guidelines 
In a letter dated July 28, 1980, Dr. Fritz 
Reusser of The Upjohn Company 
requested that two sections of Appendix 
E be amended. These sections currently 
read as follows: 
• “ Bacillus subtilis strains that do not 
carry an asporogenic mutation can be 
used as hosts specifically for the cloning 
of DNA derived from E. coli K-12 and 
Streptomyces coelicolor using NIH- 
approved Staphylococcus aureus 
plasmids as vectors under P2 conditions. 
• "Streptomyces coelicolor can be 
used as a host for the cloning of DNA 
derived from subtilis, E. coli K-12, or 
from S. aureus vectors that have been 
approved for use in B. subtilis under P2 
conditions, using as a vector any 
plasmid indigenous to Streptomyces 
coelicolor or able to replicate in that 
host by natural biological mechanisms." 
The proposed revision would permit 
additional Streptomyces species to be 
utilized in these experiments. The 
species to be added are already 
included in Appendix A, Sublists C and 
D, as two groups of Streptomycetes 
known to exchange DNA by 
physiological means. Dr. Reusser noted 
that these species are not pathogenic for 
humans, animals or plants. The 
proposed revised sections of Appendix 
E would read as follows: 
• “ Bacillus subtilis strains that do not 
carry an asporogenic mutation can be 
used as hosts specifically for the cloning 
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