Dr. Cohen called the meeting to order and asked Dr. Gartland to summarize the 
charge to the working group. Dr. Gartland responded that the working group was 
being asked to consider two issues regarding transgenic animals. The first 
issue involves transgenic animals that do not technically fall under the National 
Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA 
Molecules because the ENA introduced into tlie animal is not recombinant ENA as 
defined by the NIH Guidelines. The other issue concerns containment guidelines 
for experiments involving introduction of recombinant ENA into the genome of 
animals, particularly experiments involving introduction of DNA from human 
pathogens. 
Dr. Rapp stated that in effect one is doing a recombinant DNA experiment when 
DNA is introduced into an animal, and these experiments probably should be 
covered by the NIH Guidelines. He said that essentially the experiment is being 
done in an animal rather than in a test tube. Dr. Lang agreed and said there 
will be many more projects of this sort. 
Dr. Gottesman noted that the NIH Guidelines generally have not addressed non- 
recambinant ENA experiments. However, she noted that Section III-A-4, vhich 
refers to human gene therapy, covers "recombinant DNA or DNA or RNA derived 
from recombinant ENA." She said this kind of extension could be considered 
for transgenic animals. 
Dr. Neiman questioned what other review mechanisms are in place for these kinds 
of experiments. Dr. McKinney responded that oversight ccmmittees for experiments 
involving animals are generally not constituted to review safety. Dr. Lang said 
an animal committee may not see the entire experimental protocol. 
Dr. Gottesman noted that introduction c£ recombinant ENA into animals is covered 
by the NIH Guidelines. She said there are two issues here: (1) the experiments 
involving introduction of non- recombinant ENA into animals, and (2) review 
procedures for these experiments. 
Dr. Singer, chair of the NIH Institutional Biosafety Committee (IBC), noted 
that a piece of DNA excised from a vector is not considered to be recombinant 
ENA. She said there is a need to consider transgenic animal experiments as 
recombinant DNA experiments. 
Dr. McKinney said he is unaware of any document other than the NIH Guidelines 
that could be used to provide guidance to IBCs regarding transgenic animal 
experiments. Dr. Gottesman said there is concern about broadening the definition 
of recombinant DNA and again suggested the approach used for human gene therapy, 
i.e., including ENA derived from recombinant ENA. 
Dr. Neiman noted that there are other techniques in which there is no involvement 
of recombinant ENA, and the field of trangenic animals will have to be monitored 
as it developes. Dr. McKinney stated that the non-recanbinant experiments 
should fall under the NIH Guidelines. 
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