MINUTES OF MEETING - December 6-7 
8 
the resources available in a modem molecular biology laboratory 
are necessary to characterize the clones. An enormous expense 
would be involved if these resources had to be moved to Plum 
Island. 
Dr. Krimsky asked for more background on the conventional methods 
of producing FMD vaccine. He asked whether the recombinant 
technique would be safer than conventional techniques for produc- 
ing vaccine. Dr. Callis responded that of the estimated 800 
million doses of vaccine produced annually, the virus in about 
300 million doses is produced in explants of bovine tongue 
epithelium. Virus for about 500 million doses is produced in 
tissue culture systems. Dr. Callis said that in order to produce 
vaccine by this method, enormous quantities of virus must be 
produced with the attendant containment problems. He suggested 
that recombinant technology could produce vaccine at considerably 
less expense as a stable product, without risk of the virus 
escaping from factories. Many outbreaks today result from 
inconpletely inactivated vaccine or escape of the virus from 
factories. 
Dr. Bems asked Dr. Callis to explain how the vaccine would be 
used in case of an outbreak. Dr. Callis responded that the 
policy on FMD and other infectious foreign animal diseases is to 
eradicate them should they enter the U.S. In the case of FMD, 
eradication has been attempted by slaughter and burial or 
incineration of all infected and exposed animals. US DA policy 
for control of FMD depends on eradication, including the applica- 
tion of vaccines. He said that in an outbreak the vaccine would 
be administered to all susceptible animals within a twenty-five 
mile radius. Dr. Bems asked what role timing plays in the ring 
containment procedure. Dr. Callis responded that time is of 
essence. Dr. Novick said that the hazard of using a subgenomic 
fragment is infinitesimal in comparison to using the whole virus 
to produce vaccine and the RAC should permit the research to 
proceed. 
Dr. Goldstein said he thought the project is a worthy one. However, 
he said he is concerned because the project involves a company 
which has been in open violation of the NIH Guidelines. Dr. Ross 
responded that Genentech is not new and has not been in open 
violation of the Guidelines. Dr. Krimsky asked Dr. Gartland if 
he could provide any additional information. Dr. Gartland stated 
that under the 1976 Guidelines the only scale-up prohibition 
was against scale-up of recombinant DNAs "known to make harmful 
products." He said that the Genentech IBC made a judgment that 
the A chain and B chain insulin recombinants were not known to 
[ 401 ] 
