FEBRUARY 15-16 - MINUTES OF MEETING 
24 
B. PROPOSED RISK-ASSESSMENT PROGRAM. 
Dr. Nutter mentioned that Nl'AID is preparing plans for a 
program to assess the risks of recombinant DNA research. 
The proposed plan will be published for comment in the 
Federal Register and presented to the RAC for review. Dr. 
Rowe stated that the risk assessment program should involve 
the pulling together of existing data, as was done at the 
Falmouth Workshop. The RAC discussed Dr. Beckwith's 
letter (616) expressing concern about the construction of 
hybrid proteins. Dr. Setlow appointed a Risk Assessment 
Subcommittee consisting of Mr. Thornton (Chairman), Dr. 
Baltimore, Dr. Gottesman, Dr. Krimsky, and Dr. Williams. 
C. POLYOMA RISK ASSESSMENT EXPERIMENTS. 
Dr. Rowe summarized the results (619, 620) of the polyoma 
risk assessment experiments to date. The studies were 
designed to examine the ability of bacteria carrying a 
recombinant molecule containing polyoma DNA to cause 
polyoma virus infection in mice. In no case was polycma 
infection observed in mice or mouse cells exposed to 
bacteria carrying the recombinant molecules. In those 
cases in which a single copy of polycma DNA was con- 
tained in a recombinant molecule, injection of the recom- 
binant molecules as free DNA did not induce an infection. 
Polyoma infection was observed in seme of the mice injected 
with phage recombinants containing two copies of the polycma 
DNA. However, there was no evidence of infection in mice 
fed with bacteria carrying the double-copy polycma recom- 
binants. Dr. Rowe stated that he felt that the polyoma 
system is an appropriate model for papovaviruses and other 
DNA viruses. 
Dr. Gottesman again raised concern about the production and 
possible transport of fused proteins out of E. coli , with 
the hypothetical induction of an autoimmune response. She 
again recommended that this be considered in development 
of the risk assessment program. 
XVIII. AMENDMENT OF SECTIONS III-B-2 and III-C-5 OF THE GUIDELINES . 
The RAC considered for approval changes in the Sections III-B-2 and 
III-C-5 of the Guidelines so as to include the words "into a lambdoid 
DO] 
