UNIVERSITY OF WASHINGTON 
SEATTLE, WASHING JJONTffl 195 
Program in Social Management of Technology 
21 November 1979 
Dr. Patricia Harris 
Secretary 
Department of Health, Education and Welfare 
Washington, D.C. 20201 
Dear Dr. Harris: 
I am writing to you in regard to actions taken at the September 6-7 meeting 
of the NIH Recombinant DNA Advisory Committee and Director Fredrickson's 
recommendations to lower safety standards by exempting some 85% of 
Recombinant DNA work from the NIH Guidelines, I testified before Departmental 
officials a year ago on the proposed Guideline revisions and participated 
in a subsequent meeting 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 Senator 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. NIH has announced a proposed 
risk assessment program but has not instituted it yet, not to mention that 
there are -- of course -- no result s 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 discussed 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 espectations; that 
naked polyoma DNA can cause infection in mice, etc. 
Procedural ly also, the operations of the RAC are quite questionable. The 
RAC does not have clear procedural rules, conducts important business 
through rump minority sessions, is chaired by a person of strona biases which 
become reflected in the way the Committee does its work and in the materials 
presented to it, etc. 
314 Guggenheim, FS-13 / Telephone: (206) 343-1029 
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