Recombinant DNA Advisory Committee - 09/9-10/93 
"m-A. 
Experiments which require specific RAC review and NIH and IBC 
approval before initiation of the experiment; 
"ffl-B. 
Experiments which require NIH (Office of Recombinant DNA 
Activities/ORDA) and Institutional Biosafety Committee (IBC) 
approval before initiation of the experiment; 
"ffl-C. 
Experiments which require IBC approval before initiation of the 
experiment; 
"m-D. 
Experiments which require IBC notification at the time of the 
experiment; 
"m-E. 
Experiments which are exempt from the procedures of the 
Guidelines. 
"IF AN EXPERIMENT FALLS INTO BOTH CLASS m-A AND ONE OF THE 
OTHER CLASSES, THE RULES PERTAINING TO CLASS ffl-A MUST BE 
FOLLOWED. If an experiment falls into Class ffl-E and into either Class ffl-C 
or III-D as well, it can be considered exempt from the requirements of the 
Guidelines. Changes...." 
Section ffl-A- 1 will be moved to a new Section ffl-B- 1. New Section ffl-B is proposed to 
read: 
"Section IE-B-Experiments That Require NIH (ORDA) and IBC Approval Before 
Initiation. 
"Section III-B-1. Deliberate formation of recombinant DNA containing genes for 
the biosynthesis of toxin molecules lethal for vertebrates at an LDjo of less 
than 100 nanograms per kilogram body weight.... 
"Section HI-B-l-(a). Experiments in this category cannot be initiated without 
submission of relevant information on the proposed experiment to NIH through 
ORDA. The containment conditions for such experiments will be determined by 
ORDA in consultation with ad hoc experts. Such experiments also require the 
approval of the IBC before initiation (see Section IV-C-l-b-(3)-(f)." 
Sections III-A-2, III-A-3, III-A-4 will be renumbered to III-A-1, III-A-2, III-A-3 
respectively. Sections III-B, III-C, and III-D will be renumbered to HI-C, III-D, and III- 
E respectively. 
The new Section III-C-2 is proposed to read: 
"Section III-C-2. Experiments in Which DNA From Human or Animal Pathogens 
(Class 2, Class 3, Class 4, or Class 5 Agents [1]) is Cloned in Nonpathogenic 
Recombinant DNA Research, Volume 18 
[215] 
