16 
the field. Dr. Miller suggested a demonstration of central equivalence may 
mitigate the amount of information required in the review. 
Dr. Amtzen said including the concept of "identical" in the document would 
create insurmountable problems for individuals wishing to patent a modified 
microorganism. One of the conditions for obtaining a patent is that the 
organism is novel and unique. How could a claimant argue an organism is not 
novel or unique before RAC and then attempt to convince a patent examiner the 
organism is indeed novel, unique, and patentable? 
Dr. Gottesman ashed whether the same degree of testing should be required for 
every modified organism proposed for field testing. She thought the working 
group document should indicate some flexibility in the degree of testing required. 
Dr. Pirone felt the case-by-case approach to reviev implied flexibility. 
Dr. Colwell felt simply because a genetically engineered organism is identical 
to an organism existing in nature is not sufficient reason to exempt it from 
review. He said even if an organism is genetically identical to one seen in 
nature, it must be considered in the context of the environment into which it 
will be introduced. Dr. Miller agreed the global effect of the organism must 
be evaluated. 
Dr. Mazza said Dr. Gottesman' s proposed concept of uniqueness is logical and 
basic but is only one of several review considerations. Dr. Hollander suggested 
the preamble might simply state that uniqueness is one consideration to be 
taken into account in evaluating the modified organism for field testing. 
Dr. Tolin said the working group document should not indicate how the proposal 
will be evaluated; rather the document should simply state the types of informa- 
tion required for review. 
Dr. Gottesman argued that if the working group document does not address the 
question of uniqueness but simply assumes the organism must be reviewed because 
it is constructed using recombinant DNA techniques, organisms constructed using 
recombinant DNA will be de facto in a special class. 
Dr. Clowes said the NIH Guidelines have traditionally considered modified 
organisms for which analogues might be present in nature to be exempt from the 
NIH Guidelines. Dr. Colwell said the laboratory situation, the primary focus of 
the NIH Guidelines until recently, differs from situations in which modified 
organisms will be introduced into the environment. 
Dr. Pirone felt the data requested in the body of the working group document 
would show whether the organism is identical to organisms existing in nature. 
The investigator alone cannot make such a determination, and the preamble should 
not contain an indication that investigators might make such a determination. 
Dr. Lacy endorsed Dr. Pirone' s suggestion that the working group attempt to 
develop the data requirements of the body of the document; perhaps a mechanism 
to settle this basic disagreement in philosophy will become more obvious when 
these points have been developed. 
1193 ) 
