MINUTES OF MEETING - June 5-6 
13 
He said the workshop was to determine whether these two possibilities are 
valid scientific hypotheses, and if valid, to determine whether sufficient 
data existed to make a judgement concerning risk. If sufficient data 
were not available, the workshop was instructed to outline the studies 
necessary to develop an informational framework. He said that the major- 
ity of participants felt the issues were valid scientific questions, but 
in general, judged that risks from either of these scenarios were small. 
He said several recommendations were developed at the meeting: (1) it is 
desirable that E. coli cells carrying recombinant DNA and making a mammal- 
ian protein are introduced into living animals under conditions where 
they cause genuine infection (e.g., an abscess) with subsequent monitoring 
for breakdown of immune tolerance; (2) additional information is needed 
on the handling and absorption of polypeptides in normal and in patholo- 
gical colon, and the potential effects of synthetic polypeptides on the 
bowel; and (3) additional information is needed on the frequency of 
plasmid transfer from Escherichia coli K-12 to anaerobes in the bowel. 
A fourth recommendation was that NIH communicate with CDC concerning 
health surveillance of workers using recombinant ENA technology. 
Dr. Krause said that in order to address the first recommendation, NIAID 
will release either a Request for Proposals (RFP) or a Request for Appli- 
cations (RFA) to solicit responses from interested investigators. Tb 
address the question of handling of polypeptides by normal and patholo- 
gical colon and effects of synthetic polypeptides, Dr. Krause said that 
NIAID would cooperate with the National Institute of Arthritis, Metabolism, 
and Digestive Diseases to attempt to develop appropriate human studies. 
He said that studies currently funded by NIAID should provide information 
on the frequency of plasmid transfer from Eh_ coli K-12 to anaerobes. He 
deferred discussion of implementation of the fourth recommendation to 
Dr. Dowdle of CDC, who was present at the RAC meeting. Dr. Dowdle said 
that consideration of this topic was included in the upcoming Federal 
Interagency Subcommittee meeting agenda. 
Dr. Campbell said he concurred with Dr. Krause's summary of the Pasadena 
meeting. He added that workshop recommendations for studies in certain 
areas do not necessarily imply that such experiments are a necessary 
part of a risk assessment program; rather they may merely indicate that 
the experiment is feasible and would produce relevant knowledge. 
Dr. Krimsky said that the Pasadena transcript seemed to reflect a disil- 
lusionment with animal models in immunology. Dr. Krause said that 
tremendous amounts of information had been derived from animal models, 
but that difficulties in translating this information into an effective 
understanding of autoimmune diseases of man have been encountered. 
Mr. Pauker added that the immunologists at Pasadena did not have a con- 
census of opinion that the information derived from animal experiments 
could be directly applied to risk assessment in human beings. 
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