7 
since the group has already discussed many of these points in detail. 
Dr. Vidaver agreed most of the points raised in the comment letters were 
considered by the working group in its extensive discussions. 
Dr. Sharpies said the points to consider document represents important ccm- 
prcmises between a great diversity of opinion. She suggested the working 
group and RAC not introduce major changes in the document until the points 
to consider have been used to evaluate an actual field trial. 
Dr. Johnson said he supported the points to consider document but suggested 
that in the future consideration be given to whether certain "innocuous" 
modified organisms could be exempted frcm review like "self-cloning experi- 
ments" in the laboratory. 
Dr. Gottesman said the working group had discussed this possibility but 
could only agree that "information on all these points will not be necessary 
in all cases." She felt, however, the working group could perhaps attempt 
to distinguish cases which would not necessarily be exempt but vhich would 
not require a great deal of information for review. Dr. Gottesman said this 
approach would be in keeping with the manner in which the NIH Guidelines 
have evolved. Originally all experiments were covered by the NIH Guidelines. 
As information became available, requirements for seme categories of experi- 
ments were reduced, and same categories of experiments were eventually exempted 
from review. 
Dr. McGarrity reemphasized that modifications would be introduced into the 
points to consider document as data and experience accumulate. He expressed 
concern that this type of flexibility might not be present in oversight 
mechanisms proposed by other government agencies. 
Dr. Pirone said although certain microorganisms in their natural state are 
innocuous, they may not be innocuous when altered. The interactions of 
microorganisms in nature are not well documented, and caution is appropriate. 
Dr. Landy said he in principle supported attempts to develop categories of 
exempt organisms. However, no control would be applied over how exempt 
organisms would be introduced into the environment. Althouc^ a modified 
organism may be a variant of one occurring in nature, an investigator 
might disperse it in ways not normal in nature. While there may be no 
long-term environmental impact from such procedures, the possibility of 
transient effects should also be considered at this time. The working 
greup approach is appropriate, and the document is currently an excellent 
guide for evaluating testing of modified microorganisms in the environment. 
Dr. Clowes said the points to consider document represents a compromise 
between views of microbiologists and ecologists. Although some working 
group members felt some of the information requests were onerous and 
unnecessary, the correct approach clearly is to construct a flexible 
document to which individuals can respond as appropriate. 
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