Dr. Gottesman asked Dr. Gartland for an update on the situation 
of the amendments from the September 21, 1987, meeting. 
Dr. Gartland said tab 1322 was basically the proposed revisions 
as they emerged from the September 21, 1987, meeting. On advice 
of legal counsel an environmental assessment is being prepared 
with the assistance of the Department of Agriculture and this is 
the reason the Director has not taken final action on this issue. 
Dr. Neiman said he thought the issues raised by the NIH IBC were 
appropriate and the proposed amendments cover the loopholes that 
exist, but he felt Dr. Gottesman' s point was also valid that 
future changes may be necessary as technology progresses and 
direct introduction of DNA may become possible. However, the 
issue is speculative and not a practical issue at this point in 
time. He fully supported the limited changes to the NIH 
Guidelines proposed. 
Dr. Johnson noted he was not a member of the working group but he 
felt there was a certain amount of ambiguity and complexity of 
language in tabs 1310, 1321, and 1322 which seemed to bring into 
question whether natural mammalian reproduction would be brought 
under scrutiny in that breeding colonies of animals which 
sexually transmit the genome of interest is a basic facet of 
transgenic animal work. He said the language may be ambiguous 
enough to impede such work. 
Dr. Korwek said he was also confused and asked for a definition 
of the term "transgenic animal." Dr. Gottesman said that a 
specific definition had not been developed by the group. Dr. 
Korwek asked if rearrangements would be considered "transgenics , " 
to which Dr. Johnson replied that crossovers and rearrangements 
occur naturally. Dr. Gottesman said the phrase "stable 
introduction of DNA into the germ line," defines "transgenic" but 
the word "introduction" may be the key to determine if something 
should fall under the NIH Guidelines. 
Dr. Cohen reiterated the decision of the working group to not 
change the definition of "recombinant DNA" in the NIH Guidelines 
while at the same time having concern over containment of animals 
in which human pathogens have been inserted into the germ line . 
He said the focus was on alerting IBCs and researchers that such 
experiments may need special containment. 
Dr. Korwek said he had no problem with such a goal, but he 
expressed concern about the implementation of the language and 
whether it imposes a restriction that otherwise would not be 
there. He said he would like rearrangements to be specifically 
discussed in terms of being categorically included or excluded. 
Dr. Gottesman asked for opinions of persons more involved in the 
field as to whether rearrangement could take place using 
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