10 
lincolnensis be exempted under Section III-D-5 of the NIH Guidelines. The 
following language was proposed for inclusion in Appendix C of the NIH 
Guidelines: 
"Experiments and processes utilizing reccrrbinant ENA containing deriva- 
tives of Streptcniyces fradiae or Streptcmyces lincolnensis are exempt 
fran the Guidelines at all levels of volume scale when the reccrrbinant 
DNA molecules contained in these hosts are derived solely from nonpatho- 
genic streptornycetes . The ncrpathogenicities of the recombinant DNA 
sources are determined by the local Institutional Biosafety Committee 
(IBC) . 
"For these exempt laboratory experiments, BL1 physical containment 
conditions are reccrrmended. 
"For large-scale fermentation experiments BL1-LS physical containment 
conditions are recommended. However, following review by the IBC of 
appropriate data for a particular host-vector system some latitude 
in the application of BL1-LS requirements as outlined in Appendix 
K-II-A through K-II-F is permitted. 
" Exceptions . 
"Experiments described in Section III-A which require specific RAC 
review and NIH approval before initiation of the experiment. 
"Experiments involving Class 3, 4, or 5 organisms (1) or cells known to 
be infected with these agents may be conducted under containment condi- 
tions specified in Section III-B-2 with prior IBC review and approved. 
"Large-scale experiments (e.g. , more than 10 liters of culture) require 
prior IBC review and approval (see Section III-B-5). 
"Experiments involving the deliberate cloning of genes coding for the 
biosynthesis of molecules toxic for vertebrates (see Appendix F)." 
Dr. Clowes said a previous broader request by Dr. Manis had been rejected 
by the RAC at the February 6, 1984, meeting because sufficient background 
information had not been supplied. Dr. Manis has now limited his request 
and provided relevant information. The request cites the taxonomic rela- 
tionships between these two Streptcmyces strains and other Streptcmyces 
strains and indicates there are only two pathogens in this genus; 
Streptcmyces scmaliensis vhich produces fungal-like infections in humans 
and animals, and Streptcmyces scabies which produces a scab-like disease 
cn potatoes and sugar beets. 
Dr. Clowes found Dr. Manis' arguments persuasive. He said St reptcrryces 
lincolnensis and Streptcmyces fradiae have been used for more than twenty 
years in large-scale antibiotic preparation. Although Streptcmyces 
lincolnensis and Strep tcnyces fradiae strains have not been cultivated for 
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