Residential College 
East Quadrangle 
The University of Michigan 
Ann Arbor, Michigan 48109 
(313) 763-0176 
December 30, 1979 
The Honorable Patricia Roberts Harris 
Secretary 
Department of Health, Education, and Welfare 
Washington D.C. 20201 
Dear Secretary Harris: 
I am writing in regard to two changes in the NIH Recombinant 
DNA Guidelines published in the Federal Register on November 30th. 
I have followed closely developments in the recombinant DNA field 
during the past four years. I am engaged in an extensive study 
of the evolution of policy for recombinant DNA technology in the 
United States and Great Britain, and I also teach a course on the 
history of the recombinant DNA controversy at the University of 
Michigan. The following remarks address two aspects of the pro- 
posed actions: i) relations between the arguments advanced in the 
Federal Register and the proposed changes in controls; and ii) the 
policy implications of these changes. 
I. The "E.coli K-12/P1 proposal (p. 69218). (The arguments 
supporting this proposal are given in the NIH director's "decision 
document," p. 69234 f.) 
According to this proposal, which applies to 80-85% of all work 
in the field, experiments would require registration only with 
committees within the institutions engaged in the work. There 
would be no external oversight and the present system, which requires 
registration with the NIH Office of Recombinant DNA Activities, 
would be dismantled. Thus this proposal entails the removal of most 
of the present controls for E.coli K-12 host-vector systems. 
The justification for this major change in policy is given in 
section III-B of the "decision document," p.69236. This section 
purports to demonstrate a "low probability" for harmful effects 
from experiments conducted at the "PI" level of physical contain- 
ment. The material is organized under a series of subheadings in 
question form, such as: "What is the Likelihood of E.coli K-12 
Escape from a PI Laboratory?" I assume that these questions are 
rhetorical in thrust and that certain answers to them are implied. 
For convenience, I have numbered these subheadings "1"-"12." 
Detailed comments on this section are attached. To summarize my 
conclusions : 
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