Recombinant DNA Advisory Committee - 09/9-10/93 
Prokaryotic or Lower Eukaryotic Host-Vector Systems. 
"Section III-C-2-a. ...Many experiments in this category are exempt from the 
Guidelines (see Section III-E-4) and III-E-5). Experiments involving the 
formation of recombinant DNA for certain genes coding for molecules toxic for 
vertebrates require NIH (ORDA) approval (see Section EQ-B-1) or must be 
carried out under NIH specified conditions as described in Appendix F." 
Section IV-B-5-b-(3) is proposed to read: 
"Section IV-B-5-b-(3). Petition NIH (ORDA), with concurrence of the IBC for 
approval to conduct experiments specified in Sections III-A and UI-B of the 
Guidelines;" 
Section IV-C-l-b-(3)-(f) will be deleted which reads: "Approving the cloning of toxin 
genes in host-vector systems other than E. coli K-12 (see Appendix F); and]" 
Section IV-C-l-b-(3)-(g) will become the new Section IV-C-l-b-(3)-(f). 
The new Section IV-C-3-a is proposed to read: 
"Reviewing and approving experiments involving the cloning of genes encoding for 
toxin molecules that are lethal for vertebrates at an LDjo *100 nanograms per 
kilogram body weight in organisms other than E. coli K-12 (see Section III-B-1 
and Appendices F-I and F-II)." 
Sections IV-C-3-a and IV-C-3-b will be renumbered to become Sections IV-C-3-b and 
IV-C-3-c respectively. 
Section V-2 is proposed to read: 
"...In the cases falling under Sections III-A through m-D, this judgment is to be 
reviewed and approved by the IBC..." 
Appendix C is proposed to read: 
"Appendix C. Exemptions Under Section III-D-5. 
"..Appendix C-I. Recombinant DNA in Tissue Culture... 
"...Exceptions. The following categories are not exempt from the NIH Guidelines: 
(i) experiments described in Section III-A which require specific RAC review and 
NIH and IBC approval before initiation, (ii) experiments described in Section III- 
B which require NIH (ORDA) and IBC approval before initiation, (iii) 
experiments involving DNA from Class 3, 4, or 5 organisms [1] or cells known to 
be infected with these agents, and (iv) experiments involving the cloning of toxin 
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Recombinant DNA Research, Volume 18 
