MINUTES OF MEETING - December 6-7 
9 
make harmful products and Genentech began a scale-up in October 
1978 under the 1976 Guidelines. On December 22, 1978, the NIH 
revised the Guidelines, and these revised Guidelines went into 
effect on January 2, 1979. The revised Guidelines contain a more 
stringent standard for scale-up including approval by the Director, 
NIH. Dr. Gartland said that Genentech has stated they have not 
been in violation of the Guidelines. 
Dr. Call is stressed the point that the USDA has a committee, the 
Vectors Committee, which regulates materials shipped off Plum 
Island. He said the material to be shipped off the island will 
be subjected to stringent tests for infect ivity. Dr. Campbell 
asked whether every shipment off of the Island is approved by 
the Committee. Dr. Callis said that it is. 
Dr. Gottesman then preposed the following four-part motion: 
(1) That the RAC approve the formation of recombinants between 
Foot and Mouth Disease Virus and plasmid pBR322 as outlined 
in Stage I of the scientific plan of document #763, to take 
place at Plum Island; 
(2) That a working group be formed to examine data on the 
infectivity of sub-genomic portions of the Foot and Mouth 
Disease Virus and to examine the testing data and infectivity 
of the clones produced on Plum Island; 
The collection of clones to be approved for removal from 
Plum Island shall not contain among them the full genome 
of the Foot and Mouth Disease Virus; 
The working group shall: 
(a) be empowered to approve the continuation of the 
experiments through Stage II and Stage III, 
or, alternatively 
(a') report back to the full RAC on the infectivity data. 
The RAC will then consider approval for further stages 
of the experiment. 
and 
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