COVINGTON & BURLING 
Donald S. Fredrickson, M.D. 
March 3, 1978 
Page Fifteen 
Unfortunately, the regulatory or procedural aspects 
of the Guidelines do not meet the same high standards as 
the scientific aspects. From an administrative law stand- 
point, the Guidelines are pedestrian and, indeed, defective. 
The procedures embodied in the Guidelines simply do not re- 
flect adequate attention to elemental concepts of due pro- 
cess of law. This is understandable, since they were 
developed by scientists rather than by experts in adminis- 
trative law. 
I have identified the following 7 areas where 
specific procedures are needed and where the Guidelines 
presently set forth no applicable procedures whatever: 
1. Development, promulgation and amendment 
of a list of non-novel experiments. 
2. Exemptions for specific experiments or 
classes of experiments from the require- 
ments of the Guidelines (e.g., risk 
assessment experiments) . 
3. Future changes in the physical or bio- 
logical containment classification for 
particular experiments . 
4. Certification of host-vector systems. 
5. Large volume exceptions. 
6. Nomination and selection of members of 
the Recombinant Advisory Committee (RAC) . 
7. Future modification of the Guidelines. 
In each of these areas, a variety of models exist from which 
to develop fair administrative procedures. Without pro- 
cedures, NIH, the scientific community, and the public at 
large simply will be unable to understand how the various 
provisions in the Guidelines will be implemented. It is 
impossible to determine, for example, how one applies for 
certification of a new host-vector system, what procedure is 
applied by RAC in reviewing such an application, how the 
decision is announced, and other similar procedural details. 
As a result, it was stated during the December 1977 meeting 
that the public agenda of the RAC meeting during which certi- 
fication of the EK2 system was considered did not even mention 
that this matter was on the agenda. 
[Appendix A — 253] 
