Recombinant DNA Advisory Committee - 10/7-8/91 
a statistical plan of what the next step will be in the further study of these materials in 
patients. 
Dr. Leventhal moved to approve Dr. Rosenberg's proposal to treat five patients with IL- 
2 modified tumor cells with the stipulation that he report back to the committee on local 
and systemic toxicity and efficacy of the treatment. Dr. Kelley seconded the motion. 
Dr. B. Murray put the motion to a vote. The motion passed by a vote of 17 in favor, 0 
opposed, and 1 abstention. 
Dr. B. Murray returned the Chair to Dr. McGarrity. 
Dr. McGarrity announced that if the discussion of the next agenda item finishes early, 
there has been a request that the committee begin the discussion of the agenda item for 
tomorrow regarding the future role of the HGTS. 
V. PROPOSED AMENDMENT TO APPENDICES B-I-B-l AND B-I-B-2 OF THE NIH 
GUIDELINES REGARDING THE BACTERIAL ORDER ACTINOMYCETALES 
Dr. Schaechter stated that the proposal deals with the molecular manipulation of 
organisms which are quite important to industry, in the production of antibiotics, as well 
as other uses. However, there is concern that in this group of organisms, 
Actinomycetales , there are some known pathogens and a large number of suspected 
pathogens. In May 1991, the Mid Atlantic Biological Safety Association, represented 
today by Dr. Fleming, asked the committee to remove the gram-negative bacteria in the 
group of Actinomycetales from the NIH Guidelines for two reasons: (1) This group of 
organisms was originally classified as fungi. Actinomycetales is now classified as bacteria. 
(2) The list was quite inclusive. In the current NIH Guidelines, Appendix B-I-B-2, 
Fungal Agents, lists Actinomycetes, including Nocardia species, Actinomyces species and 
Arachnia propionica. It is not clear which are included and which are excluded under the 
term "Nocardia species" and "Actinomyces species." It could be interpreted as all 
inclusive or partially so. The Mid Atlantic Biological Safety Association has proposed 
that the list include only known pathogens in order to make the list inclusive as opposed 
to exclusive. The problem was that the committee was given numerous classification lists 
and did not know which ones were considered likely pathogens. 
Dr. Schaechter explained that the Actinomycetales have been difficult to classify by 
taxonomists; consequently, there have been a lot of name changes. These organisms are 
known for causing a number of diseases. The current proposal by Dr. Fleming is based 
on a consultation with experts at the Centers for Disease Control (CDC), and with Dr. 
Beaman at the University of California at Davis who discussed a German assessment of 
risk in this group. The results are a list of Actinomycetales considered to have "proven 
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Recombinant DNA Research, Volume 15 
