Dr. Donald S. Frederickson 
Page 2 
September 1, 1978 
nonlaboratory hosts. Any proposed system must fulfill both requirements. 
As a non-scientist, I am not competent to comment on the adequacy 
of these two biological-containment requirements or on the potential 
or lack of hazard in any of the proposed alternative host-vector systems. 
From a procedural standpoint I am concerned that the current requirements 
for HV-1 certification may be insufficiently flexible to respond to new 
scientific developments, some of which may provide an even greater 
measure of safety than the EK systems. 
There are at least two ways in which this flexibility could be 
incorporated into the guidelines during the present cycle of revision. 
The first would be to reconceptualize the two requirements for HV-1 
certification as criteria. With this approach, both criteria would 
always be taken into account, but not every certified host-vector 
system would need to fulfill both criteria. For example, the survival 
of baker's yeast hosts and vectors in their natural habitat might not 
constitute a biohazard, if one were certain that the DNA contained in 
those hosts and vectors would not be transmitted to other cells or 
organisms. 
A more general approach would be to build into this revision of the 
guidelines a procedural mechanism for minor or partial revisions of the 
guidelines in the future. What I have in mind is a six-month cycle in 
which a revision would be discussed and drafted at one meeting of the 
NIH Recombinant Advisory Committee (RAC) , published in the Federal 
Register for written comment, reassessed at the next RAC meeting in 
light of the written comments and oral public comments made at the meeting, 
redrafted by NIH staff in light of the public comments and Committee 
recommendations, and published in final form in the Federal Register 
approximately six months after the beginning of the revision process. 
With this procedure minor deficiencies in the guidelines could be 
rectified without the time investment required for comprehensive 
revision. 
Sincerely yours 
Director, Center for Bioethics 
Kennedy Institute 
LW:mt 
CC: Dr. William Gar t land 
Dr. Jane Setlow 
[A-76] 
