Page 22 of Attachment E 
Section IV 
REPORT FROM COGENE’S OBSERVER AT THE 
FALMOUTH WORKSHOP ON RISK ASSESSMENT 
The following report was sent on June 24, 1977 in the form of a 
memorandum to members of the COGENE Working Group on Risk 
Assessment, from Dr. A.M. Skalka, who attended the Workshop as an 
official observer for COGENE. Although informal, it received rather wide 
distribution owing to the delay in publication of the more formal report 
(to be published in the Journal of Infectious Diseases, May 1978) and the 
need for information on this subject. 
A workshop on Studies for Assessments of Potential Risks 
Associated with Recombinant DNA Experimentation, sponsored by 
the National Institutes of Allergy and Infectious Disease and the 
Fogarty International Center of the National Institutes of Health, was 
held on June 20-21, 1977 in Falmouth, Mass. 
The stated objectives of this meeting as outlined in the letter of 
invitation which is included in the material attached, was to con- 
centrate on five major areas. 
1. Consideration of the possibility that there would be a 
change in the biology of E. coli K-12 after incorporation of 
a random piece of foreign DNA from various eukaryotic 
sources. 
2. Consideration of changes brought about by the insertion 
of animal virus DNA. 
3. Consideration of the biology and pathogenicity of E. coli 
K-12 not carrying recombinant DNA molecules. 
4. Consideration of maintenance and spread of plasmids of 
E. coli K-12 in vivo. 
5. Consideration of the “hypothetical barrier " which has 
been proposed to prevent the uptake of eukaryotic DNA by 
prokaryotic cells. 
As indicated by the schedule of topics and speakers for the 
meetings, these various areas were not considered in turn, rather the 
conference started- with a discussion of the consideration of the 
biology of E. coli and the relevant host defenses. Of considerable 
interest, were a series of experiments presented by Dr. S. Formal, in 
which exhaustive attempts were made to induce pathogenicity in E. 
coli by deliberate insertion of a number of genes from Shigella 
flexneri. The results from all these attempts (which took place over 
several years) were essentially negative. Thus, even in this well- 
defined system, where assays for pathogenicity and virulence were 
available and conscious attempts were made to introduce genes that 
would render E. coli pathogenic, no success could be reported. 
These data together with the fund of knowledge already available 
from the infectious disease and epidemiology experts present, led to 
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