SECTION I 
I. INTRODUCTION 
In his introductory statement, the Director of the 
National Institutes of Health (NIH) asserts that five years 
after the molecular biology community first expressed concern 
about the risks of recombinant DNA, " ... no evidence has come 
to light of a product created by these techniques that has been 
harmful to man or the environment." He concludes, "At the 
least, there is growing sentiment that the burden of proof is 
shifting towards those who would restrict recombinant DNA 
research." (43 FR 33044). This syllogism, that NIH's failure 
to find evidence of harm requires a shift in the burden of 
proof , is the central reason for the proposed weakening of the 
NIH Guidelines for Recombinant DNA Research (43 FR 33042, 
July 28, 1978; hereafter proposed revised guidelines). 
NIH's logic is faulty; the failure to find evidence of 
harm primarily reflects NIH's failure to look. No comprehensive 
risk assessment program for recombinant DNA has ever been 
proposed or initiated. The appropriate response to the 
present dearth of information about the risks is not to 
reduce required levels of containment and ease procedures for 
enforcement of the guidelines, but to initiate and fund 
research that will provide a base for a sounder evaluation 
of risks. 
[A-176] 
