Dr. William J. Gartland, Jr. 
January 22, 1987 
Section II 
IBA supports the proposed revision to Section III-A-2 and the 
development of the associated appendices M,N, and 0. This would 
refine the definition of deliberate release that was acted upon at 
the NIH-RAC meeting of September 29, 1986. In addition, it goes a 
step further in establishing criteria for appropriate environmental 
releases of recombinant organisms. 
Having established guidelines will ultimately expedite 
experiments with those recombinant organisms where adequate 
physical and/or biological control can be demonstrated. It 
important in the implementation of this proposal to convene 
groups with the appropriate scientific expertise to develop 
appendices M, N, and 0. 
Section III 
IBA supports the full intent of the proposal set forth 
section and we suggest that NIH-RAC select Option 1. It is 
important to note that there is no difference between those 
microorganisms created through recombinant DNA technology that are 
phenotypical ly the same as might arise naturally or through 
traditional genetic manipulations such as mutation and selection. 
Hence, the exemption from the Guidelines of those organisms 
composed of single base changes, deletions, and rearrangements 
within a single genome are based on sound scientific principals; 
their naturally occurring counterparts have caused little concern 
in the past. 
Because Option 1 changes the definition of recombinant DNA at 
the outset of the Guidelines, IBA believes that this will add more 
clarity. It will insure that there is no ambiguity as to when an 
organism is defined as recombinant, regardless whether research on 
this organism is conducted in a contained or field environment. 
Option 2 may confuse some individuals because it will be located in 
a later section that is meant to define "deliberate release". 
Section IV 
IBA supports the proposed changes in this section that are 
offered by FDA Commissioner Frank Young. The increasing commercial 
applications of biotechnology in health care and other fields have 
necessitated the large scale production of recombinant 
microorganisms. Virtually all of the research and development work 
as well as production has involved microbial host-vector constructs 
that are exempt from the laboratory research guidelines. 
field 
is 
working 
in this 
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