COVINGTON 5, BURLING 
Donald S. Fredrickson, M.D. 
March 3, 1978 
Page Seventeen 
meetings has had anything less than a full opportunity to 
present views both orally and in writing. You have shown 
your full sensitivity to the concept of procedural due pro- 
cess in those meetings. That same sensitivity now needs 
to be reflected in specific procedural provisions in the 
Guidelines . 
Serious questions were also raised about the 
adequacy of the environmental impact statement on the 
original Guidelines, which were not answered. Moreover, 
it appears that no draft environmental impact statement 
has yet been prepared for the proposed revision of the 
Guidelines. Greater care and attention should be paid to 
the requirements of the National Environmental Policy Act 
in order to assure the procedural integrity of the Guide- 
lines . 
VII 
The discussion at the December 1977 meeting also 
revealed 4 areas that, in my judgment, deserve greater NIH 
priority even though they do not relate to any specific 
change in the provisions of the Guidelines at this time. 
1. At present, it appears that scientists 
knowledgeable in the field are unable to develop objective 
criteria for classifying host-vector systems. As I have 
already stated, I am not surprised or troubled by the fact 
that some areas in the Guidelines require the use of sub- 
jective or vague terminology, reflecting the need for ex- 
pert judgment. Nonetheless, NIH should take the lead in 
attempting to develop objective criteria that can be includ- 
ed in the Guidelines in the future. 
2. It is evident that there are differences among 
scientists throughout the world with respect to the risks 
presented by various types of research on recombinant DNA 
molecules. The area of greatest evident dispute involves 
research on viruses, which is apparently permitted under P3 
conditions in Europe but requires P4 conditions in the 
United States. NIH should actively pursue this matter on 
an International basis, to reconcile these differences. If 
the United States requirements are in fact too stringent, 
the full scientific justification for reclassifying these or 
other experiments should be made public and appropriate 
[Appendix A — 255] 
