15 
specifies that deliberate release into the environment of any organism containing 
recombinant Dt^ must be specifically considered and approved by the NIH and. 
the IBC. This language should be all inclusive and not limited to testing in 
the environment. She said individuals may wish to dump viable modified organisms 
into the environment; this is clearly not testing and would not be covered by 
a specification referring only to testing. If the NIH Guidelines were modified 
to require review only for environmental testing, modified organisms could be 
freely dumped into the environment but could not be field tested without exten- 
sive testing. 
Dr. Miller suggestel the working group specifically exempt from the points to 
consider document those applications such as vaccines over vshich other agencies 
have jurisdiction. Dr. Gottesman said the working group might at some point 
consider this suggestion but not before completion of the working group document. 
Dr. McGarrity agreed; he urged the working group to continue with its evaluation 
of the working group document. 
Dr. Gottesman proposed the following two points be included in the preamble of 
the working group document: 
"1. How different is the organism from its parental organism? 
"(a) The special attention given to recombinant DNA. containing organisms 
is based on the assumption that the organism being considered did 
not exist before in nature and, therefore, may have seme unexpected 
properties. If the organism is identical to one found in nature, 
then it can be treated in the same way as the natural analogue. 
"(b) If the modified organism is similar to an organism found in nature, 
predictions of its properties will depend on a comparison between 
the modified organism and its parent. 
"2. What will be the probable effect on the environment of the release of 
this modified organism? Will it grew and survive? Will it transfer 
genetic information to other organisms? How will it interact with 
other organisms?" 
Dr. Arntzen felt Item l-(a) of Dr. Gottesman' s proposed language should not 
be included in the preamble of the working group document. He argued that the 
use of the word "identical" splits hairs. How would the investigator prove the 
organism was identical to the parent organism? Would the genetic map or the 
entire sequence of the genome be required to prove the organisms are identical? 
Dr. Pirone agreed; he did not feel the degree of relatedness between the modified 
and the parent organism would determine whether the organism could be field 
tested or not. Rather the evaluation would have to be made on the basis of 
predicted properties. 
Dr. Clowes said he preferred the preamble include the language proposed by 
Dr. Gottesman. He said engineered organisms analogous to organisms in nature 
would net require extensive testing in growth chambers and greenhouses before 
testing in the environment nor would they require extensive monitoring once in 
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