COVINGTON & BURLING 
Donald S. Fredrickson, M.D. 
February 20, 1976 
Page Seven 
ments are inadequate to assure appropriate activity. The more 
specific the requirement, the greater will be the adherence 
to it . 
I was struck, for example, by two points raised by Dr. 
Barkley in his slide presentation. He pointed out that an 
ordinary kitchen blender should not be used but, if it is used, 
the lid should be kept on it for ten minutes after use. He also 
said that a P-3 area should not have access to a well-travelled 
corridor. I then looked in the guidelines and could find 
neither of these concepts stated as requirements. Nor is there 
anything in the guidelines which states the minimum level of 
scientific training and experience necessary to conduct any of 
these experiments (e.g., either the number of years of work in 
the field or the level of education received) . Some reference 
was made at the meeting to other NIH publications which discuss 
some, but apparently not all, of these matters, but those other 
publications are not even referenced in the guidelines, much 
less incorporated as requirements. It appears to me either that 
those other publications should be incorporated as requirements, 
and perhaps supplemented by additional requirements in the guide- 
lines, or all of these detailed requirements should be spelled 
out in the guidelines themselves. It simply is not adequate to 
refer to acceptable practices, with the vaguest of generalized 
descriptions, since this is tantamount to no requirement whatever. 
11. A number of people pointed out that the concept of 
"99% purity" should be fully defined, and the guidelines should 
either contain a scientific procedure for determining this level 
of purity or require approval of such material by the NIH Advisory 
Committee . 
Ill 
The procedural status of the guidelines raises both 
legal and policy issues. 
The initial purpose of the guidelines is to determine 
the circumstances under which NIH will fund recombinant DNA 
molecule experimentation. Obviously, NIH intends to enforce 
the guidelines by granting or denying funds. Under these circum- 
stances, it seems disingenuous to call the document "guidelines." 
It is intended to be rigidly enforced by NIH, and therefore has 
the same legal status as a regulation, rule, or even a statute. 
[ 480 ] 
