14 
Dr. Bems moved acceptance of the language in the Federal Register . 
Dr. Gottesman asked if the levels specified in the working group proposal 
were higher or lower than the case-by-case assignments which have been 
made to date under the current Section III-C-l-e-(l)-(b) . Dr. Barban 
replied that in the use of SV40 in some rescue experiments, containment 
is currently P3, and would, if this proposal were adopted, be P2. 
Dr. Novick asked Dr. Bems to review the issues. Dr. Bems said the major 
consideration is whether splicing of various viral genomes might produce 
a pathogen more dangerous than the parent viruses themselves. The working 
group consensus was that no indicat ion suggested this possibility. 
Dr. Bems said viruses are the product of millions of years of evolution, 
and are selected for optimal function. 
By a vote of ten in favor, five opposed and one abstention, the RAC recan- 
mended the revision of Section III-C-l-e-(l)-(b) of the Guidelines as 
published in the Federal Register on August 21, 1980. 
XIII. REQUEST TO INCLUDE VIBRIO CHOLERAE IN APPENDIX A 
Dr. Gottesman presented the request (tabs 909, 931/12) from Dr. John A. 
Mekalanos, Harvard Medical School, to add Vibrio cholerae to sublist A, 
Appendix A of the Guidelines. She said Dr. Mekalanos has presented data 
showing evidence of R factor transfer. Dr. Gottesman said that recombi- 
nant ENA experiments between organisms within each sublist of Appendix A 
are exempt from the Guidelines under Section I-E-4. Section I-E-4 exempts 
"certain specified recombinant ENA molecules that consist entirely of 
DNA segments from different species that exchange DNA by known physiolog- 
ical processes ..." 
Dr. Gottesman said a discussion has continued concerning the criteria 
required to qualify organisms for inclusion in Appendix A. She said the 
issue revolved on whether R factor transfer was sufficient or whether 
evidence of chromosomal exchange should be required. Committee members 
have previously argued that where R factor exchange occurs, chromosomal 
exchange, if looked for assiduously, probably would be found. She said 
she has differed with the committee on this interpretation, and that her 
inclination would be to require evidence of chromosomal transfer. 
Dr. Novick expressed some concern over the pathogenic nature of Vibrio 
cholerae but qualified his statement with the following points: (1) a 
virulent E. coll producing cholera toxin probably would not be worse than 
a virulent~E. coli producing E. coli enterotoxin; and (2) cholera toxin 
is processed - in V^_ cholerae ; E. coli may not be able to produce ah active 
toxin. He suggested that certain experiments might be permitted under PI 
+ EKl containment conditions, but that V^ cholerae should not be added to 
Sublist A of Appendix A. Dr. Mason concurred. 
[ 173 ] 
