24 
S. venezuelae) are on two sublists of Appendix A. He said he felt 
TSixmfortable with giving carte blanche permission to work with any 
species the investigator deems to be norpathogenic . Dr. 
with Dr. McGarrity. He said that specific species could be added to 
Appendix A as data cure evaluated. He said he had no reservations about 
permitting scale-up of recombinant Streptomyces cultures. 
Dr. Gottesman said the Guidelines currently permit large-scale operations 
with nonpathogenic Streptomyces at Pl-LS containment conditions . following 
IBC review. Dr. Gottesrran said she could not s upport Ear. Manis prcpos 
as no data had been included in support of the proposal. 
Dr. Muth of Eli Lilly and Canpany said Eli Lilly had screened ever 300,000 
isolates of Actinomyces most of vhich were Streptomyces . Of these, pro- 
bably 500 species have been grown on a large scale and eight 
been grown in 10,000 to 50,000 gallon fermenters. More than 1,000 Eli Lilly 
employees have been involved in various aspects of antibiotic production 
with Str eptomyces . No cases of infection with Streptomycgs have been 
observed /SV Muth said Eli Lilly has concluded that Streptoiyces may be 
used safely in large-scale operations. He supported Dr. Manis 1 proposal. 
Dr. McKinney said Dr. Manis had supplied no supporting documentation. 
Dr. McGarrity was also opposed to approving a one page proposal with no 
supporting data. 
Dr. Sharpies found disturbing the argument that genetically combining two 
nonpathogens will invariably guarantee a nonpathogenic product. 
Dr?Alexander said certain Streptoiyces are plant pathogens . The SSS 
impact of the proposed manipulations on plant disease nust be conside 
as well as the relevancy of Streptoiyces to human disease. He said very 
little is known about the mechanisms of Streptoiyces pathogenied/ty in 
plants. Before any carte blanche approvals are given such informa tio 
should be available. 
Dr. McKinney moved that the proposal be rejected. Dr • JJlcwes 
notion. Dr. Muth asked if this proposal could be raranded to the Large- 
Scale Review Working Group for further evaluatfon. ^. Mc^rrity 
review of this type of proposal is not the responsibility of the Larg 
Scale Review Wbrk!£g Group particularly in view of the paucity of informa- 
tion forwarded by the investigator. 
By a vote of fifteen in favor, none oppos ed, a nd two abstentions, RAC 
approved the motion to reject Dr. Manis’ proposal. 
ANNOUNCEMENT O0NGERNIN5 APPELLATE OCXJRT RULING AN D OTH ER ANNOUNCEMEN TS 
Mr. Mitchell said that the Foundation on Economic Trends had 
January 31, 1984, a request for the court to issue a ta*i»rary i 
order (as part of Civil Action No. 83-2714) to prevent RAC from holding a 
[269] 
