Jane K. Setlow, Ph.D. 
Page 2 
Vector Systems from the guidelines. Of these 15, at least three or perhaps four 
were new members (Dr. Harris, also a new member, may have been present on 
September 6; I did not see her on September 7), leaving 12 members who could 
place these discussions in the context of what went before. According to the 
press and a letter from Richard Goldstein, when the vote was taken on the 
E. Coli K-12 issue, four members dissented and one abstained. The recommen- 
dation passed on the vote of ten persons, perhaps including one or more new 
members, out of 24 or 25 RAC members. Again, I don't know what briefing the 
new members received prior to the taking of this vote. 
What concerns me is not so much the scientific validity backing the recom- 
mendation for exemption of E. Coli K-12 Host Vector Systems from the guidelines, 
but that such a recommendation should be based on the judgement of a minority 
of the membership of the RAC. Also, while the minutes of the previous meeting 
do discuss the need for a clarification of technical issues for the lay members 
of the committee, and while I realize that this is a time consuming effort, as 
a newcomer I didn't have the sense that the new people (lay or not) were 
adequately prepared for taking action on this most important issue. 
I am also concerned that, in the rush to complete a crowded agenda, 
important recommendations may be made with inadequate discussion, or lack of 
postponement if a fair representation of the whole committee's opinion cannot 
be obtained. Perhaps the action that was taken on this particular item and 
on several of the others at that meeting will prove to be correct. But, as a 
newcomer, I felt confused and more than a bit uncomfortable about such an 
important recommendation being made the way that it appeared to be . 
I did receive a copy of the letter written by Richard Goldstein on this 
matter and I share some of his concerns. However, even before receiving his 
letter, I had been planning to write to you on these matters. I will certainly 
be prepared for the forthcoming meeting and I hope to be a more active and 
helpful participant of RAC at that time. I realize that you have an immensely 
difficult task in chairing this committee, and that the difficulties are com- 
pounded by the pressures of time. If there is any way that I can be of help, 
please let me know. 
Sincerely, 
Elena 0. Nightingale, M.D. , Ph.D 
Director 
Division of Health Promotion 
and Disease Prevention 
EON/dtg 
cc: Dr. Donald S. Frederickson 
Dr. Richard Goldstein 
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