Dr. Gottesman suggested that the proposed introductory paragraph 
to Section III-B-4 of the NIH Guidelines be amended to read: 
"This section covers experiments involving whole 
animals, both those in which the animal's genome has 
been altered by stable introduction of recombinant DNA 
or RNA , or DNA or RNA derived therefrom, into the germ 
line (transgenic animals) and experiments involving 
viable recombinant-DNA-modif ied microorganisms tested 
on whole animals. For the latter, other than viruses 
which are only vertically transmitted, the experiments 
may not be carried out at BL1-N containment; a minimum 
containment of BL1 or BL2-N is required." 
Dr. Davis said he was reluctant to introduce the word 
"recombinant" because historically the RAC has tried to emphasize 
the principle that what is of concern is the nature of the 
organism and not the technique by which it was formed and he said 
this suggested wording added emphasis to the concept that process 
was more important than product. 
Dr. Childress said, as a newcomer, he wanted to know what the 
background of the issue was and whether it was going to be 
addressed in any other forum. Dr. Gartland reiterated the 
history of the matter. He said the NIH Biosafety Committee had 
proposed that all transgenics should be covered by the NIH 
Guidelines, but they did not define "transgenic." A working 
group had been set up by the RAC to look into the matter and tab 
1321 is the report of that working group. He said that no other 
group, at this point, is constituted to look at this issue. 
Dr. Gartland said the committee had two options: one, to 
restrict the proposed revision of the NIH Guidelines to covering 
"recombinant DNA" and advise the Director of NIH that there may 
be a broader problem; or two, take the position that most of the 
concerns will be resolved by this limited modification of the NIH 
Guidelines . 
Dr. Gottesman suggested she go through the working group 
recommendations one at a time to indicate where they fit into the 
NIH Guidelines. 
Recommendation A refers to the incorporation of the following 
language in Section II of the NIH Guidelines: 
"Biosafety Level 1 for animals (BL1-N) describes 
containment which is used for animals in which the germ 
line has been modified through recombinant DNA 
techniques (transgenic animals) and is designed to 
eliminate the possibility of sexual transmission of the 
modified genome or transmission of recombinant-DNA- 
derived viruses known to be transmitted only vertically 
(i.e., transmitted from animal parent to offspring only 
Recombinant DNA Research, Volume 13 
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