May 21-23 - MINUTES OF MEETING 
17 
Several commentators had requested that this section be broadened to 
permit the heterologous transfer of ENA segments to a eukaryote other 
than the host of origin. A broader proposal could not be considered 
at the February 15-lb, 1979 RAC meeting as it would have required an 
opportunity for public comment. The following proposed revision of 
Section III-C-6 was published in the Federal Register on April 13, 1979 
for a 30-day comment period prior to its consideration at the May meeting: 
"III-C-6. Transfer of Cloned ENA Segments to 
Eukaryotic Organisms . ENA from any nonprchibited 
source [Section I-D] which had been cloned and 
propagated in E. col i under appropriate physical 
containment conditions, may be transferred with 
the E. coli vector used for cloning to a eukaryotic 
organism or cells in culture and propagated under 
conditions of physical containment comparable to 
PI and appropriate to the organism under study [2A] ." 
Several letters were received during the comment period which supported 
this proposal. Recent experimental results have demonstrated that it 
is possible to transfer ENA to eukaryotic organisms without a requirement 
for the DNA to be part of a recombinant ENA molecule. The major difference 
in the interspecies experiments which involve using recombinant DNA 
techniques is that there will be an association of the E. coli vector 
DNA with the DNA of interest. The recombinant ENA methods also allow 
a more controlled process since it permits the use of selected genes. 
Drs. Beatrice Mintz and Jerome Freed of the Institute for Cancer Research, 
Philadelphia, Pennsylvania, presented background information on the prcposal. 
A very important category of experiments which this amendment would permit 
involves the cloning of ENA frcm one higher eukaryote into Eh coli , 
followed by the transfer to an embryo or teratoma of another eukaryote. 
This procedure will make possiole the study of the genetic basis of various 
diseases by isolating individual genes and examining their expression in 
various whole animals. There will be the possibility of understanding 
the basis for cell diversification during development of higher organisms 
and the organization of genetic information. These features may be 
important in many cases to understanding the origins of malignant growth 
and the genetic basis of disease. As noted by one commentator, this 
research may lead to the possible cure of human genetic diseases. 
One commentator indicated that this prcposal would, in essence, allow 
for nearly any eukaryote to become a host for any DNA; this would not be 
in the spirit of the Guidelines. Another commentator noted that any 
experiments that involved the return of cloned ENA to humans would 
require the examination by human experimentation committees . 
[ 112 ] 
