MINUTES OF MEETING - December 6-7 
7 
Dr. Goldstein asked Dr. Call is to discuss the problem of vaccine 
efficacy. Dr. Callis responded that approximately 800 million 
doses of vaccine are used yearly worldwide. Dr. Goldstein asked 
if antigenic drift occurs in FMD. Dr. Callis responded that a 
drift does occur but not to the extent as in influenza. He said 
there are seven immunological types of FMD and approximately 
sixty-five subtypes. 
Dr. Ahmed then proposed an amendment to Dr. Baltimore's motion. 
He suggested the addition of a requirement that no material be 
removed from Plum Island until all the relevant data have been 
reviewed by the RAC following review by a working group. 
Dr. Young suggested approving the project in principle with the 
qualification that the data be reviewed before the material is 
transported from Plum Island. Dr. Ahmed asked whether the 
subgenomic fragments would be considered a Class 5 agent. 
Dr. Young responded that organisms are classified as pathogens 
in their natural state. Non-infectious fragments would not be 
equated with a Class 5 agent. 
Dr. Novick asked whether there could be recombination between 
FMD virus and related viruses that are not Class 5 agents. 
Dr. Baltimore agreed that it could occur but said that such an 
event is highly unlikely. Dr. Bachrach said that there is 
evidence of cross encapsidation but not of recombination between 
bovine enterovirus and FMD. 
Dr. Gottesman said that the FMD proposal could be broken down 
into three issues. She suggested that the RAC deal with them 
and vote on them one-by-one. She said that the first issue is 
the making of the clones on Plum Island. She noted that there 
appears to be an agreement on this phase. The second issue 
deals with what further approval is required before the clones 
are to leave Plum Island. She suggested that the RAC could 
review the data on the L fragment, the data on the clones which 
will be generated on Plum Island, and the results of infectivity 
testing. Ihe third issue is the appropriate containment for 
the work in California. Dr. Ahmed said that he was not 
comfortable with only a subcommittee reviewing the data. 
Dr. Nightingale noted this is the first request for an exception 
to a prohibition. She expressed concern that one of the reasons 
given for removing the clones from Plum Island was the convenience 
of the researchers. Dr. Ross responded that it is not simply a 
question of inconvenience of the researchers. He said that all 
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