Guidelines (e.g., those in Section III-A-2) . Therefore, the 
working group presented two options for public ccrunent and RAC 
consideration. 
Dr. McGarrity said the working group had overwhelmingly favored 
Option 2 as published in the Federal Register as the preferred 
choice by a vote of 9 in favor, 1 opposed, and no abstentions. 
Dr. McGarrity added that he felt perhaps the working group's 
choice had been swayed by an opinion offered by a lawyer on the 
working group that to change the definition was more radical than 
changing other portions of the NIH Guidelines. Dr. McGarrity 
reviewed the major changes proposed in the two options. Dr. 
Gotteanan reviewed sane of the public canments received on the 
two options. She pointed out that option one would eliminate 
from RAC review certain hunan gene therapy experiments but that 
option two would leave review of such experiments within the 
purview of RAC. 
Drs. Korwek, Sharpies, Clowes, and Cohen all said they preferred 
Option 2 to Option 1. 
Dr. Neiman said that at the previous RAC meeting he had stated 
that rearrangements, deletions, and amplifications within higher 
organisms that do not rapidly change their genomes are not 
necessarily as innocent as those that occur in microorganisms. 
Therefore, he felt that modification of Section III-A-2 of the 
NIH Guidelines would be a more favorable approach than a change 
in the definition of "recombinant DNA. “ 
Dr. Korwek moved that further consideration of Option 1 be 
rejected, and Dr. Epstein seconded the motion. Mr. Mitchell 
called for discussion on the motion and called on Dr. Henry 
Miller from FDA. Dr. Miller said FDA's view was that the purpose 
of the NIH Guidelines was to circumscribe a unique or special set 
of experiments and organisms that required some special 
attention, not necessarily due to risk involved, but due instead 
to the use of recombinant DNA in cases which did not occur 
naturally or were special in seme other way. Because of this. 
Option 1 is preferred. Option 1 would say that it isn't simply 
cutting and ligating that defines recombinant DNA in a meaningful 
way; rather it is the joining of heterologous DNAs . He said that 
changing the definition of "recombinant DNA" right up front was 
clearer than altering it by changing exemptions. 
Dr. Davis agreed with Dr. Miller. He felt it would better guide 
the courts in making it clear that even if recombinant DNA 
technology was used, that in our judgnent no recombinant DNA 
existed unless heterologous segments were introduced into the 
gencme. This would appropriately shift emphasis from the 
procedure to the product. The basic issue is whether the product 
contains foreign DNA. He said he could not vote for Option 1 as 
written because the use of the word "organism" in the proposed 
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