Page 2 of Attachment F 
SECOND REPORT OF THE COGENE 
WORKING GROUP ON RISK ASSESSMENT 
A. M. Skalka 
Department ot Ceil Biology, 
Roche Institute of Molecular Biology, 
N utley, NJ. 07110, U.SA 
COGENE's Working Group on Risk Assessment was established in May 1977 in 
response to concerns regarding the safety of recombinant DNA technology. Its 
members include: Drs. Giorgio Bernardi (France), Vittorio Sgaramella (Italy), 
and more recently. Dr. Natalie Teich (U.K.) with myself as convener. At its 
formation, the Group outlined two objectives. One was to gather information to 
be considered in the assessment of risks. The second was to identify possible 
areas from which additional relevant information might be obtained, and, if 
studies in such areas were not already underway, to consider their sponsorship. 
In July of 1978, COGENE made public the first report from this Working Group'''. 
This two part, 319 page report contains a variety of information including 
responses to a questionnaire sent to various international organizations and 
evaluation of their significance, reports of various meetings and hearings as 
well as comments on relevant information from the literature and opinions of 
individual scientists. 
Analysis of this information indicated that the concerns regarding recombinant 
DNA research could be grouped into three major categories: 
1. Organisms carrying recombinant DNA may spread in the natural 
environment and disrupt existing ecological equilibria. 
2. These organisms might produce some toxic or noxious substance, 
or otherwise cause disease. 
3. By exploiting this technology, scientists may be crossing some 
hypothetical barrier to DNA exchange between eukaryotes and pro- 
karyotes and thus affect pathogenicity or dispersion of pathological 
agents. 
Reports from the Falmouth Meeting (June, 1977) and COGENE-sponsored analyses of 
E. coli K-12 systems, both discussed in the report, showed that many relevant 
experiments had already been conducted by scientists in such closely related 
fields as epidemiology and infectious diseases. Their observations that E. coli 
J-Copies of the report are available from COGENE (c/o Dr. W. J. Whelan) P.O. Box 
016129, Miami, Fla. 33101, U.S.A. 
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