Dr. D. S. Fredrickson 
- 2 - 
May 2, 1978 
B. Much discussion occurred in the Committee regarding the use of 
Saccharomyces cerevisiae as a cloning host. It was suggested that all such 
experiments be exempted from the Guidelines. I oppose this move. The point 
was carefully made that although genetic transfer out of S^. cerevisiae does 
not exist, the yeast does survive. As a free - 1 ivinq , non-disabled organism, 
harmful products could be introduced into the environment -- for example, 
hormones or toxins. I would suggest that these experiments remain under the 
Guidelines, at the PI or P2 level, until the development and certification 
of a disabled yeast strain with reduced natural survival meeting the criteria 
for HV-1 systems. 
C. In general, I agree with the Animal Virus and EMBO Revisions for 
animal virus work. I would suggest that PI NM (PI no mouth pipetting) be 
made P2 -- there being no operational difference, and as stated above, I 
believe it would make the Guidelines more observed. 
D. As a former bacterial geneticist, and presently as an animal virolo- 
gist, I would concur with the reports of both the EMBO workshop and the Animal 
Virus Working Group and recommend that n^o mouth pipetting be allowed in PI, 
as well as P2-P4 containment. This is not a hardship to experimental protocol, 
using present devices. 
II. Administrative Comments 
A. Much of the flak you will catch will, I believe, come from exempting 
experiments from the Guidelines. I would suggest that all experiments involving 
recombinant technology be registered with NIH (through use of the checkoff box 
on grant applications and continuations) and with local IBCs. This registration 
need not be time consuming, but it would allow keeping track of who is doing what 
B. If you truly expect these Guidelines to be respected, I would suggest 
that the ultimate penalty for violation be made identical to the penalties 
enforced for violations of the Human Experimentation Institutional Review Board. 
C. Much of the responsibility for interpreting the Proposed Guidelines 
will rest with local IBCs. Would it be possible for the revision to exp! icitly 
state that the local IBC can refer to either the RAC or ORDA for advice or inter- 
pretation in complex cases. 
Thank you for your consideration of my comments; you have my sympathy for 
what will be a scientifically difficult and politically impossible set of 
decisions. 
Sincerely, 
/ 
Philip J. Lai pis, Ph.D. 
Assistant Professor 
PJL: sf 
Attachment 
[Appendix A — 294] 
