Tab C - Page 18 
Dr. William J. Gartland 
Page 2 
May 14, 1985 
recombinant organisms have been described is at best 
premature. It is a bit like asking for a description of 
the long-term effects of the discovery of x-rays on our 
civilization immediately after Rontgen showed the 
invisible radiation would penetrate some objects and not 
others and that these effects could be measured. Science 
deals with limited extrapolation from known experimental 
results; the data from one experiment must be digested 
and interpreted before the next can begin. 
There can never be an original experiment with zero 
risk. With admirable caution, the NIH-Recombinant DNA 
Advisory Committee (RAC) has recommended approval of 
experiments that carefully probe new areas of application 
of recombinant DNA technology. The field test proposal 
of Drs. Lindow and Panopoulos is such an experiment. The 
environmental assessment prepared by NIH summarizes 
current knowledge about all factors bearing on possible 
environmental effects; we concur with the logical con- 
clusion that no significant environmental impact should 
result. The EPA has requested additional information 
from the submitters before issuing an Experimental Use 
Permit (EUP) [the agency decided an EUP would be required]; 
however, these do not appear to be aimed at any previously 
unknown facts about the organism or the experimental 
conditions that would suggest that the environmental 
assessment was in error. What this action does suggest, 
however, is that experimental field tests and other 
experiments involving recombinant organisms may require 
the collection, assembly, and submission of an inordinate 
amount of information in defense of protocols that, in 
many instances, simply duplicate in a more refined way 
the processes of genetic recombination that exist 
naturally in the biosphere. 
It is appropriate to begin consideration of certain 
categories of recombinant DNA experiments involving 
release of innocuously different organisms (in terms of 
their defined genomic changes) as being exempt from these 
requirements for extensive background information based 
on the fact that such changes occur naturally — and often 
with less precision. Of course, there are experiments 
that should not be classed as exempt at this stage, , 
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