Recombinant DNA Advisory Committee - 10/7-8/91 
Dr. B. Murray said it would be easier if the five specific organisms that are now being 
used, and have been used for a long period of time, were considered separately. There 
is a whole variety of these organisms described in the clinical literature. For instance, 
there are many reports on Actinomadura madurae of association with tumor. 
Dr. Fleming said that in 1988, the organism Streptomyces lividens was brought before the 
committee by SmithKline Beecham. They were asked to go back to the CDC for 
reference as to whether it was pathogenic for humans. This last year, several of these 
organisms were brought to her attention by some of the groups in her organization. 
These organisms had been modified with recombinant DNA techniques to produce a 
secondary metabolite for use as an antibiotic or anti-tumor agent. She said that it 
seemed feasible to ask the committee to look at this whole group of organisms. 
Ms. Buc said there is a hazard question and a taxonomy question. Perhaps the 
committee should only address the hazard question. The organisms should be grouped 
by hazard. 
Dr. Kelley moved that this issue be sent to an organization, like the American Society of 
Microbiology (ASM), to ask for advice. Dr. Post seconded the motion. 
Dr. Atlas said that they should establish a working group to bring in consultants from the 
appropriate organizations and come back with a recommendation to the RAC. 
Mr. Barton added that the working group should be free to assess the species that are 
most important commercially. Ms. Buc agreed and suggested that the group of 
companies propose the ten safest Actinomycetes for exemption. Dr. Post asked if the 
companies could come up with a list of organisms they want reclassified, and possibly a 
list of organisms that are already being used safely under good industrial large-scale 
practices. 
Dr. Fleming said that some of those organisms are included in the back of the index of 
the Industricd Biosafety Manual; there is a list of Streptomyces and Nocardia that have 
been used for the production of antibiotics and anti-tumor agents. There are not many 
pathogens on the list, which is the reason for the requested exclusion of those organisms 
from Appendix B. 
Mr. Capron said that the proposed working group should be given some instruction as to 
whether they should try to avoid risks or try to encourage the development with some 
tolerance of a level of risk and uncertainty. If this is largely a group of organisms that is 
not very pathogenic, but has certain known pathogens, then the listing only the latter in 
Appendix B would make sense. If this is a black box where little is known, that 
introduces another set of problems. 
Recombinant DNA Research, Volume 15 
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