UNIVERSITY OF CALIFORNIA, BERKELEY 
BERKELEY • DAVIS • IRVINE • LOS ANGELES • RIVERSIDE • SAN DIEGO • SAN FRANCISCO 
DEPARTMENT OF BIOCHEMISTRY BERKELEY, CALIFORNIA 94720 
December 28, 1979 
Dr. Donald S. Fredrickson 
Director, National Institutes of Health 
Building 1 , Room 124 
Bethesda, MD 20205 
Dear Dr. Fredrickson: 
This letter is in response to your request for comments on the 
proposed revisions of the guidelines governing recombinant DNA research 
published Friday, November 30, 1979. Our Institutional Biosafety 
Committee met on December 20, 1979, to discuss the revisions, primarily 
the "E. coli K12/P1 Recombination," Section IIIE, page 69245. 
The committee strongly supports this proposal insofar as it reflects 
the deregulation of this class of experiments in response to the accumu- 
lation of considerable evidence that E_. col i K12 is not a plausible epidemic 
pathogen. However, the committee was nearly unanimous in feeling that there 
is an inconsistency in reducing the containment level of these experiments 
with organisms of no known pathogenic potential to PI, yet maintaining 
Federal supervision of these experiments, as implied in the new registration 
procedure. The effect of the action is to continue or increase an already 
onerous administrative load on the IBC's while at the same time abolishing 
all but token containment. It is not argued by anyone that PI level contain- 
ment will prevent laboratory infection of workers in the event a true 
pathogen is involved. Hence, unless there is some evidence of pathogenicity, 
we feel there is no justification for continued regulation, and we urge that 
the original RAC proposal to exempt these E_. col i K12 experiments be recon- 
sidered. Such exemption would in no way preclude IBC's from registering 
relevant experiments and monitoring a PI level containment. However, it 
would eliminate the Federal role in mandating the procedures to be followed. 
It may have been overlooked in the considerations of this issue that 
the original justification for the adoption of Federal regulations governing 
recombinant DNA work was the threat of the construction of a novel epidemic 
pathogen in the absence of concrete knowledge as to the properties of 
recombinant organisms. This led to the unprecedented decision to regulate 
all such work at public and private institutions regardless of its source of 
funding in the complete absence of any evidence of hazard. After nearly 
eight years of study there is well documented evidence as to the lack of 
novel hazard. We feel that to continue Federal regulation after evidence 
has been obtained that there is no clear threat to the public health is a 
waste of already dwindling Federal scientific resources and in addition, 
sets an ominous precedent for future Federal regulatory adventures. In 
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