Mr. Mitchell asked Dr. Gottesman to clarify the wording of 
paragraph 37. Dr. Gottesman stated that paragraph 37 would read: 
"Recombinant DNA, or RNA molecules derived 
therefrom, from any source except for a 
eukaryotic viral genome may be transferred to 
any non-human vertebrate or any invertebrate 
organism and propagated under conditions of 
physical containment comparable to BL1 or 
BL1-N and appropriate to the organism under 
study [2]. Animals containing sequences from 
viral vectors, if the sequences do not lead 
to transmissible infection either directly or 
indirectly as a result of complementation or 
recombination animals may be propagated under 
conditions of physical containment comparable 
to BL1 or BL1-N and appropriate to the 
organism under study. ..." 
Dr. Gottesman said the paragraph then would remain unchanged from 
the beginning of the next sentence, i.e., "For experiments...." 
Dr. Davis asked if this exempted anything new. Dr. Gottesman 
assured him it did not and it brought everything back to the BL1 
level. Dr. Davis asked if there was justification for making it 
"all transgenic animals." Dr. Gottesman replied that her reading 
is that transgenics without viral vectors were at the BL1 level 
as published in the Federal Register . This could possibly exempt 
some transgenics with a small amount of virus but which were not 
transmitting it. Dr. Gottesman said she believed it to be more 
consistent to exempt transgenics in a more orderly fashion. It 
was not the intent of the working group to look at this issue. 
In order to do so at this point, it would require justification 
not addressed in any of the material before the committee. The 
situation at this point is that no genetic changes in transgenics 
are exempted, and this proposal will not change that. 
Dr. Davis asked if people who are doing research with transgenic 
animals have been consulted. Dr. Erickson replied that anyone 
who makes a lot of transgenics currently is doing so at BL1. 
Dr. Epstein asked if an exemption could be voted on at this 
meeting. Mr. Mitchell said it could not. Dr. Epstein said that 
if such an exemption were desired, it could be brought up at a 
future meeting. Dr. Davis added that he felt as with bacteria 
the scientific knowledge base was strong enough to avoid 
burdening people with BL1 requirements when dealing with harmless 
experiments in animals and that such simplifications were 
desirable. 
Recombinant DNA Research, Volume 13 
[65] 
