COVINGTON 5, BURLING 
Donald S. Fredrickson, M.D. 
March 3, 1978 
Page Six 
raising in my letter of February 20, 1976 specific questions 
and suggestions for modification. I felt that your response 
to the suggestions that I and others made about the draft 
Guidelines at that time were fully and fairly covered in 
your preamble to the final Guidelines. 
In my judgment, the data and information accumulated 
since the final Guidelines were promulgated, and which were 
made available at the December 1977 meeting, support the 
modifications of the Guidelines that you have now proposed, 
although I again set out in this letter some specific ques- 
tions and comments for your consideration. I agree that 
there is both scientific evidence and a growing scientific 
concensus that this type of research can reasonably be pur- 
sued with greater assurance of safety than scientists once 
thought, and that some experiments can now be exempted from 
the Guidelines and others can be reclassified to lower physical 
or biological containment levels. I also anticipate that, 
as further evidence of safety is obtained, still further 
loosening of restrictions will be permissible in the future. 
This is, of course, an on-going process which can never be 
allowed to remain static. 
IV 
Regrettably, however, the procedure that has been 
followed in pursuing these modifications of the Guidelines 
has been inadequate. The preamble to the proposed revision 
of the Guidelines published in the Federal Register of Septem- 
ber 27, 1977 (42 F.R. 49596) is short to the point of being 
wholly uninformative. It contains neither the helpful back- 
ground information distributed at the December 1977 meeting 
nor any of the other unpublished or published scientific data 
and information to which reference was made at that meeting 
as the basis for the judgment that increasing evidence of 
safety justifies modification of the Guidelines. 
A proper preamble would specify each proposed re- 
vision of the Guidelines, explain the impact of those pro- 
posed revisions, state why there is less concern about 
potential risk now than there was when the Guidelines were 
promulgated, provide the published and unpublished data and 
information on the basis of which that determination has 
been made, and thus contain a thorough explanation of the 
decisional process. This would provide a basis on which 
both scientists and the general public could understand the 
reasons for the proposal and submit appropriate comment. 
[Appendix A — 244] 
