DEPARTMENT OF MICROBIOLOGY AND MOLECULAR GENETICS 
HARVARD MEDICAL SCHOOL 
25 Shattuck Street 
BOSTON, MASSACHUSETTS 02115 
14 September 1979 
Dr. Donald S. Fredrickson 
Director 
National Institutes of Health 
Bethesda, Maryland 20205 
Dear Dr. Fredrickson: 
I write in reference to recent actions of the Recombinant DNA 
Advisory Committee during the meeting held September 6-7. 
I believe it important that you are made aware of the fact that 
a minority of the total RAC members (i.e. 10 of 25) were allowed to 
pass on the major action to exempt E_. col i K12 host recombinant DNA 
studies from the present NIH guidelines. That less than a simple 
majority of authorized RAC members can exempt 80-85% of current 
recombinant DNA studies from NIH regulation makes me seriously 
question the legitimacy of the RAC to carry out its advisory role 
in a democratic fashion. 
Procedural questions are not my only concern with respect to 
the above decision by the RAC. This important decision was also 
premature in terms of the present risk assessment studies being 
carried out by NIH contractors. What is most ironic here is that 
some of these ongoing studies address the most pertinent question 
involved with E. coli K-12 recombinant DNA work -- the transfer 
of a recombinant segment to other hosts. Rather than focusing 
on this question, which was at the heart of the discussions at 
the Falmouth Risk Assessement Meeting, the chairperson allowed 
the presentation of unpublished and unverified studies by industrial 
representatives in favor of the E_. col i K12 exemption and the 
over 10 liter exemption. 
I do hope you will consider what I have mentioned above before 
you accept or reject the exemption on the E_. col i K12 work. The 
situation at the recent RAC meeting has given me reason to consider 
resignation from the RAC. I know my feelings are shared by several 
other RAC members. 
I look forward to your reply. 
Sincerely, 
Associate Professor 
[ 324 ] 
