Dr. Cohen said the working group defined "transgenic" as an 
animal in which the germ line had been altered by stable 
introduction of DNA. He said the working group had been 
cognizant that such experiments could be conducted using either 
recombinant or non-recombinant DNA and that the NIH Guidelines 
should cover certain types of recombinant transgenic animal 
experiments. However, the consensus of the group was that 
individual sections of the NIH Guidelines be modified regarding 
transgenics, rather than to attempt to modify the definition of 
"recombinant DNA." Such changes were presented in tab 1321, 
items A through F. within these suggested amendments to the NIH 
Guidelines were cautionary statements that proper containment 
must be adhered to when utilizing transgenic animals in which 
increased transmission of a recombinant pathogen or production of 
undesirable traits in a host animal could occur. 
Dr. Gottesman said there were complications in that the 
Recombinant DNA Advisory Committee (RAC) had recommended to the 
Director, NIH, that certain changes be made to the NIH Guidelines 
at the RAC meeting of September 21, 1987, and in fact, some of 
the working group recommendations are to amend the same sections 
awaiting the Director's action. 
Dr. Gottesman noted the NIH IBC had initiated thinking on 
broadening coverage of transgenic animals by requesting guidance 
from the Office of Recombinant DNA Activities (ORDA) . The IBC 
had understood that if a transgenic animal is made using 
recombinant DNA technology that it is covered by the NIH 
Guidelines because the molecule which is the source of the new 
DNA is recombinant. However, they sought an answer to a case in 
which a gene is cloned and cut away from its vector and then the 
gene, apart from the vector, is introduced in the germ line to 
make a transgenic animal. The question is whether such 
experiments should fall under the purview of the NIH Guidelines. 
Dr. Gottesman said the human gene therapy situation is the model 
on which the working group chose to base its recommendations. 
The NIH Guidelines state that recombinant DNA or DNA or RNA 
derived therefrom, if used in human gene therapy, will be 
covered. However, this approach would not cover experiments in 
which transgenic animals were made without ever going through a 
recombinant DNA stage. Dr. Gottesman said she felt there was no 
way to close all loopholes without changing definitions within 
the NIH Guidelines dramatically and that the working group had 
made the clear decision they did not wish to change the basic 
definition of recombinant DNA which has been in use for over ten 
years . 
Dr. McGarrity said he felt it was an important point that the 
Director of NIH had not acted on previous relevant amendments to 
the NIH Guidelines and that it complicated this discussion. 
Recombinant DNA Research, Volume 13 
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