10 
other parts of the research continuum would be reviewed; and (2) emphasize 
that the evaluation would be based on such information. The document as written 
suggests that RAC and working group review will not necessarily be based on 
information generated on a research continuum. 
Dr. Miller thought including language in the preamble on "uniqueness" introduces 
the concept of risk management into the document. He questioned whether the 
working group should discuss risk management in a points to consider document. 
Dr. Pirone said the body of the working group document should focus on data 
requirements which would permit evaluation of the uniqueness of the modified 
organism and the potential environmental effects of the modified organism. 
Dr. Colwell suggested the following sentence be added to the first paragraph 
of the preamble: 
"The objective of this review procedure is to evaluate the likelihood of 
adverse effects of environmental testing and application of microorganisms 
modified by reccmbinant DNA techniques." 
Dr. Lacy suggested Dr. Colwell's preposed sentence be modified to read as 
follows : 
"The objective of this review procedure is to evaluate the environmental 
effects of environmental testing and applications of microorganisms modified 
by recombinant DNA techniques." 
Dr. Clowes suggested the language proposed by Dr. Colwell should reflect the 
title of the working group document vhich should read as follows: 
"Points to Consider for Submissions Involving Testing in the Environment of 
Organisms Derived by Recombinant DNA Techniques." 
Dr. Pirone agreed with Dr. Clowes that the word "application" should not be 
included in the sentence proposed by Dr. Colwell nor in the title. He said 
"application" had not been defined and could be interpreted to mean a variety 
of procedures. 
Dr. Gartland asked vhy the working group was deleting the word "application" 
from the proposed language; proposals dealing with large-scale applications as 
opposed to limited field testing might be submitted to the NIH for review under 
the current NIH Guidelines. Dr. Gottesman thought the working group should 
first attempt to develop a document dealing with limited field tests; different 
points to consider may be necessary for large-scale applications. 
Dr. Gottesman suggested the following sentence from the draft preamble should 
follow Dr. Colwell's proposed sentence: 
"The special concern given to the reccmbinant DNA containing organisms is 
based on the assumption that the organism being considered did not exist 
before in nature and, therefore*, may have some unexpected properties." 
[187] 
