Recombinant DNA Advisory Committee - 09/9-10/93 
Appendix F is proposed to read: 
"Appendix F. Containment Conditions for Cloning of Genes Coding for the 
Biosynthesis of Molecules Toxic for Vertebrates. 
"Appendix F-I. General Information. 
"Appendix F specifies the containment to be used for the deliberate cloning of 
genes coding for the biosynthesis of molecules toxic for vertebrates. The cloning 
of genes coding for molecules toxic for vertebrates that have an LX)^ of < 100 
nanograms per kilogram body weight (e.g., microbial toxins such as the botulinum 
toxins, tetanus toxin, diphtheria toxin. Shigella dysenteriae neurotoxin) are covered 
under Section III-B-1 of the Guidelines and require NIH (ORDA) and IBC 
approval before initiation. No specific restrictions shall apply to the cloning of 
genes if the protein specified by the gene has an LD^ of 100 micrograms or more 
per kilogram of body weight. Experiments involving genes coding for toxin 
molecules with an LD^, of < 100 micrograms and > 100 nanograms per kilogram 
body weight require registration with ORDA and IBC approval prior to initiating 
the experiments. A list of toxin molecules classified as to LDjo is available from 
ORDA. Testing procedures for determining toxicity of toxin molecules not on the 
list are available from ORDA. The results of such tests shall be forwarded to 
ORDA, which will consult with ad hoc experts, prior to inclusion of the molecules 
on the list (see Section IV-C-l-b-(2)-(e))... 
"Appendix F-III. Containment Conditions for Cloning Toxin Molecule Genes in 
Organisms Other Than E. coli K-12. 
"Requests involving the cloning of genes coding for molecules toxic for vertebrates 
at an LDjo of less than 100 nanograms per kilogram body weight in host-vector 
systems other than E. coli K-12 will be evaluated by NIH (ORDA) in consultation 
with ad hoc toxin experts (see Sections III-B and IV-C-l-b-(3)-(f). 
"Appendix F-IV. Specific Approvals. 
"An updated list of experiments involving the deliberate formation of recombinant 
DNA containing genes coding for toxins lethal for vertebrates at an LD50 of less 
than 100 nanograms per kilogram body weight is available from the Office of 
Recombinant DNA Activities, National Institutes of Health, Building 31, Room 
4B11, Bethesda, Maryland 20892." 
Appendix F-IV-A through Appendix F-IV-K would be deleted. [A list of these specific 
approvals will be maintained in ORDA.] 
Committee Motion 
The RAC approved a motion made by Mr. Capron and seconded by Dr. Post to accept 
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