UNIVERSITY OF WASHINGTON 
SEATTLE, WASHINGTON 98195 
Program in Social Management of Technology 
October 8, 1979 
Dr. Donald Fredrickson 
Director 
National Institutes of Health 
Bethesda, MD 20014 
Dear Dr. Fredrickson: 
I am writing to you in regard to actions taken at the Sept. 6-7 meeting 
of the Recombinant DNA Advisory Committee. As you may remember, I testified 
before you and other Departmental officials a year ago on the proposed 
Guideline revisions and participated in a subsequent meeting you held with 
about 10 public interest representatives. I am a member of the IBC here at 
the University of Washington, and was nominated for RAC membership by 
Sen. Magnuson. 
I am dismayed by the RAC proposals to exempt E_. col i K12 host research from 
the Guidelines and permitting exemptions for the 10-liter limit on culture 
volume, and I urge you to reject these recommendations. 
First of all, as I have stated on several occasions, proper science as well 
as proper regulatory practice would seem to require that risk assessment 
activities be carried out prior to widespread experimentation and especially 
to widespread unregulated experimentation. You have announced a proposed 
risk assessment program but have not instituted it yet, not to mention that 
there are -- of course -- no results from such a program on which to base 
exemptions . 
I am aware that certain studies funded by NIH may have some utility re: 
risk assessment; indeed, I have discassed these extensively with Dr. John 
Nutter. But these studies are clearly not sufficient, and have already 
produced results which should lead us to a more cautious and conservative 
regulatory approach -- e.g., that supposedly debilitated strains of E. col i 
can survive in numbers and duration far in excess of expectations, that 
naked polyoma DNA can cause infection in mice, etc. 
Procedural ly also, the operations of the RAC are quite questionnable. The 
RAC does not have clear procedural rules, conducts important business 
through rump minority sessions, is chaired by a person of strong biases which 
become reflected in the way the Committee does its work and the materials 
presented to it, etc. 
[346] 
314 Guggenheim, FS—15 I Telephone: (206) 543-7029 
