3 
I. CALL TO ORDER AND CT>ENING REMARKS 
Mr. Ray Thornton, Chairman, called the meeting to order at 9:00 a.m., 
on February 8, 1982. He introduced two new members of the Recombinant 
ENA Advisory Committee: E)r. David Friedman, Professor of Microbiology at 
the Dhiversity of Michigan and Dr. David Martin, Professor of Medicine and 
Chief of Medical Genetics at the thiversity of California Medical Center, 
San Francisco. 
II. MINUTES OF THE SEPTEMBER 10-11, 1981, MEETING 
Mr. Thornton asked Er. McGarrity to conment on the minutes (tab 1061) 
of the September 10-11, 1981, meeting. Dr. McGarrity said the minutes 
accurately reflected the September meeting, and moved that they be accepted. 
Dr. Pedoroff seconded the motion. Dr. McKinney requested a clarification 
of the language in Section XVI, Containment Conditions for Cloning and 
E^^ression of ENA Coding for Diphtheria Toxin . He suggested the language 
should be clarified to read: 
"Dr. McKinney suggested RAC specify that the work be conducted 
in P3 laboratories in Building 550 of the Frederick Cancer Research 
Center under conditions specified by the local IBC." 
Mr. Thornton called the question on the motion to accept the minutes 
with the clarified language. The motion was unanimously acc^ted. 
III. RISK ASSESSMENT STUDIES 
Mr. Tliomton invited Dr. Levine to present the sunmary of recombinant 
DNA risk assessment studies at tab 1057. Dr. Levine said that fran the 
early days of recombinant ENA teohnology there has been oonoem about 
measures used to oontain genetic recombinants. Sophisticated physical 
containment facilities can provide containment, however, such facilities 
are expensive to construct and to maintain. On the other hand, a degree 
of biological containment can be ctotained, inexpensively, by selecting 
"safe" poorly mobilizable plasmids as dealing vectors and by using as 
hosts bacterial strains that do not colonize the human intestine. 
The degree to vhich poorly mctoilizable "safe" plasmids can or cannot be 
transferred from bacterium to bacterium within the human intestinal milieu 
is a critical assessment of containability. The Falmouth Conference on 
Recombinant INA in 1977 formally addressed the question of plasmid irobili- 
zability; the conferees recommended that risk assessment studies, consisting 
of feeding human volunteers ^ ooli K-12 with various plasmids, be performed. 
In 1979, an ad hoc Working Gtoup for Risk Assessment was convened at NIH. 
At that meetup , experts reviewed the Falmouth protocol and pointed out 
that it would not be feasible to evaluate plasmid transfer using E. coli 
K-12 as the host, since E. coli K-12 does not colonize the human Intestine 
and is rather rapidly eliminated from the bowel. An ^ coli K-12 strain 
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