13 
VIII. CLOSED SESSION 
The RAC went into closed session to consider propo6^ds from oornmercial 
ooncems for scale-up of reoonbinant experiments. 
DC. PROPOSAI^ TD CLONE GEHES OF POCT AND M0C7IH DISEASE VIRUS 
Dr. Gartland introduced a request (tab 972)/ cfated October 17, 1980, from 
(Jenentech, Inc., and the United States Department of Agriculture Plum 
Island Animed Disease Center concerning the cloning of the Foot and 
Mouth Disease Virus (FMEV) genane. An earlier proposed entitled "Cloning 
and Expression in E. ooli of the VP3 Protein of Foot and Mouth Disease 
Virus" had been renewed by the RAC at the Decentjer 6-7, 1979 meeting. 
On the reccnren<tation of the RAC, Stage I of that proposal, the construc- 
tion of clones containing cDNA segments of the FMEV genome, was epproved 
by the NIH amd announced in the Feder^ Register of January 17, 1980 (45 
FR 3552). At that time it was noted "Dr. Canpbell stated that it was 
the sense of the RAC that this motion constituted the 'major action' 
and that future recommendations of the RAC approving further stages of 
the experiment would be 'minor actions.'" Subsequently, permission was 
given ( Federal Register of July 29, 1980 (45 FR 50528)) that certain 
clones oontaIniriigcDfK~copi^ of the FMEV genome trade on Plum Island 
could be removed from Plum Island as they "were well characterized, 
lacked infectivity, and represent, in aggregate, only 75% of the FMDV 
gencme." Dr. Gartland said request one in the October 17, 1980, proposal 
dealing with work in ^ ooli K-12 could be considered a "minor action" 
continuation of the previously revie%#ed proposal. However, request two 
of the October 17, 1980, submission dealing with proposed work in hosts 
other than E. ooli could not be so considered. Dr. Gartland suggested 
RAC might tHeref'ore appropriately evaluate request one (but not request 
two) of the sutmission, even though the proposal (tab 972) had not been 
published in the Federal Register for thirty days of public corment, as 
the request had not been revived by ORDA until December 1980. 
Drs. Bems, Gottesnan and Baltimore agreed that request one of the pro- 
posal could be appropriately considered .at this meeting. 
Dr. Baltimore, in reviewing request one of the proposed, explained that 
severed types and subtypes of Foot and Mouth Disease Virus are endemic 
in the world today. He said vaccine pro(Xx»rs must thus develop vaccines 
against multiple types and subtypes of the virus. He said Genentech, 
Inc., in the original proposed, had chosen one FMIV type as a prototype, 
requested and obtained NIH permission for experiments involving this 
ty^, and now is requesting permission to a|^ly the same procedures to 
other FMEV serological types. Dr. Baltimore said Genentech, Inc., had 
agreed to abide by the oo^itions set by RAC. Dr. Canpbell said it was 
appropriate that a RAC working group, but not the full RAC, review data 
on the infectivity of the clones before they are removed fronr Plum Island. 
(411 
