6 
yeast). Nevertheless, the environmental assessment leaves the impression that 
the question of safety has been resolved for the whole range of recombinant DNA 
work involving organisms besides E. coli, even though there has been nothing 
like the analysis of other organisms which has gone into E. coli K-12. This 
serious omission is illustrative of the self-serving nature of the environmen- 
tal assessment. 
Another glaring omission is the failure to discuss the striking differ- 
ences in the guidelines of other countries, which was noted by Dr. W. J. Whelan 
in his testimony at this hearing. In addition, there is no detailed analysis 
of the numerous changes in containment levels, or explanations for specific 
changes and what, if any, data supports each change. Ten "criteria" are set 
out in the environmental assessment, but no attempt is made to explicate how 
they were applied in making changes in containment levels. This should be 
clearly and succinctly done for each change. 
The preceding discussion is only illustrative of the kinds of defects in 
the environmental assessment. It is not meant to be exhaustive. As I have al- 
ready stated, a detailed environmental impact statement must be prepared on the 
proposed revisions, and I recommend that the NIH consult with the many govern- 
mental agencies, private organizations and individuals who are concerned about 
recombinant DNA activities during the preparation of this document in order to 
insure that these concerns will be dealt with in a most efficient manner. 
RECOMMENDATIONS 
General recommendations 
1. The "Recombinant DNA Research Guidelines" should be re-entitled, "Re- 
combinant DNA Research Regulations". The guidelines have in fact been regula- 
tions all along, a point emphasized as long ago as 1976 by Peter Hutt. Calling 
[A-237] 
