November 22, 1982 
William J. Gartland, Jr., Ph.D. 
Page Three 
physically removed from our facility, and requiring the distribution of 
printed information by mail, is not an efficient way to comply with other 
federal and state guidelines and regulations. Most of these simply re- 
quire compliance with little need for decision making. Perhaps the IBC 
would be more useful if the IBC chairman was given more discretion to give 
initial approval to experiments with eventual approval of the whole 
committee . 
In summary, I would make the following recommendations for revisions in the 
Guidel ines : 
1. All experiments for which containment is specified should be allowed to 
proceed without prior IBC approval (as in paragraph 1 1 1 - C ) once the IBC 
chairman has determined that the PI has properly classified the experiment. 
2. In paragraph III-B-2-a, experiments with DNA from organisms in Class 2 
and subgenomic DNA from organisms in Class 3 and 4, as well as Class 5 if 
certified virus-free, should be allowed at PI containment. 
3. In paragraph III-B-4-a, experiments containing less than 75% of any 
viral genome or where the animal is not a viral host should be allowed at 
containment comparable to PI without the requirement to show lack of produc- 
tive infection, and without prior IBC approval as in paragraph 1 1 1 - C . 
4. For large scale experiments, the facilities and equipment should be 
given a one time prior approval by the IBC at a specified P-LS level. All 
subsequent experiments should be allowed to commence without prior IBC 
approval (as in paragraph 1 1 1 - C ) once the IBC chairman has determined that 
the PI has properly classified the experiment with PI = Pl-LS, and P2 = P2-LS. 
5. The exception for large scale experiments in Appendix C- II, III and IV 
should be removed. 
6. Exempt from the Guidelines sterile sub-unit vaccines produced with 
recombinant DNA plasmids, containing less than 75% of any viral family genome. 
Sincerely yours, 
WilTiam P. Pilacinski, Ph.D. 
Senior Scientist 
Chairman, IBC Committee 
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