is premature to exempt all releases involving all classes of genetic 
change within virtually any genome from all review. (In particular, this 
exemption includes eukaryotic genomes even though the rationale for it is 
largely based on prokaryotes.) A low level of review, similar to that outlined 
in Appendix L, coupled with more specific exemptions that can emerge from 
experience with, rather than conjecture about, releases is far more 
appropriate for the organisms covered by the Working Group's proposition. An 
additional benefit of low level review is that releases would be registered 
and thus a safety record would develop. 
Definition of Recombinant DNA 
The definition of recombinant DNA should not be revised so that it 
includes only organisms altered with "foreign" DNA. The rationale presented 
at the Working Group meeting, for implementing that group's proposition as a 
change in definition instead of an exemption, is that recombinant DNA created 
with "foreign" DNA is different from recombinant DNA created from material 
within a genome. But of course DNA does not differ among species or strains, 
and, although exchange within genomes is undoubtedly more common than exchange 
between genomes in nature, exchange between genomes does occur. Thus the 
difference between recombinant DNA created with "foreign" and "non- foreign" 
DNA is quantitative rather than qualitative. 
Such a change in definition will have far-reaching and probably 
unintended effects. Will parts of the Guidelines no longer function as 
intended? For example, will recombinant pathogens containing no "foreign" DNA 
be exempt from review? Can any organism with altered genes for toxins or drug 
resistance be released? (If not, does this mean that the definition of 
recombinant DNA depends on what organism is genetically altered?) How many 
rearrangements, amplifications, deletions, and single-base changes can be made 
and the "same" genome maintained? This last question may seem silly, given 
the atmosphere of good faith in which RAC operates. But, in order to maintain 
consistency under the Coordinated Framework for Biotechnology this revised 
definition would probably also be used for regulatory purposes, in which good 
faith cannot always be assumed. 
In closing, I wish to note that the Federal Register note concerning the 
Working Group's sentiments about changing the definition of recombinant DNA 
was misleading. Calling the Working Group "split" as to whether they wished 
to change the definition of recombinant DNA does not adequately portray the 
fact that the group voted against changing the definition, 2-7-1. 
SECTION IV 
Consideration of Section IV raises two questions. First, why should BL1 
containment be relaxed for laboratory experiments covered by Appendices C-II, 
C-III, and C-IV? The BL1 containment guidelines are hardly unreasonable; 
beyond standard microbiological practices essentially all they stipulate is 
that laboratories be designed for ready cleaning, pest control be practiced, 
and any uncontaminated wastes be transported from laboratories in closed 
containers. Second, why not simply revise these appendices so that unwieldy, 
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