Dr. Donald S. Fredrickson 
Page Two 
September 26, 1979 
more time is required for E^. coli K-12 risk assessment information to be circulated 
and commented upon. Although there has been some publication of risk assessment 
results in journals, a good deal of this information remains in progress reports for 
contract studies, technical bulletins and other sources that are less accessible to 
the scientific community than traditional journals. There has also been relatively 
little time for commentary on and confirmation of results. A number of results 
really call for more commentary and more work; for example: 1) In addition to 
l presenting evidence that polyoma virus DNA carried by E^. coli hosts is not infective, 
these risk assessment experiments also indicated that free polyoma DNA is infective. 
2) Some of the articles in the recent Recombinant DNA Technical Bulletin (Vol. 2, 
No. 2, July 1979) suggest that the invivo survival rate of E^. coli K-12 is better 
than it was previously thought to be and that the carriage of plasmids may, in fact, 
enhance the invivo fitness of "disarmed" strains of £. coli K-12. 
In addition to the preceding "scientific" reasons against complete exemption of 
£. coli K-12 work, which I personally consider to be sufficient, there also seem 
to be compelling social-political reasons not to make this precipitious a change in 
the Guidelines at this time. Although the period of genetic engineering hysteria 
seems to be over, alas the seeds of anxiety have been sown. I expect that it would 
be extremely difficult to demonstrate that a novel pathogen or some uncharacterized 
disorder is the product of synthetic recombinant DNA procedures. However, it would 
also be equally difficult to refute such an assertion. Statistical arguments (e.g. 
such as those used in defense of delayed carcinogen effects of nuclear bomb testing), 
a priori evolutionary arguments, or esoteric molecular biological evidence would be 
difficult to convince an anxious, doubting public and head-hunting press with, even 
if those arguments and evidence are formally valid. It seems that the key to winning 
such confrontations lies as much in having the public's confidence, as it does in the 
weight of evidence available. I L^lieve that this confidence can only be maintained 
through absolute openess and extraordinary prudence. It seems unlikely that public 
support for biological research could withstand an incident analagous to that at 
Three Mile Island. 
As evidence builds up to support the proposition that recombinant DNA cloning 
in £. coli K-12 hosts are safe procedures, it is appropriate that the regulations 
governing these procedures should be relaxed, with the end point of this "relaxation" 
being complete exemption. However, for the reasons presented in the above paragraphs, 
I don't believe that the proposed exemption is justified or is the best course of 
action at this time. A significant but more modest change in the IS. coli K-12 cloning 
regulations seems to me to offer a more reasonable alternative. In this relaxation 
process, particular emphasis should be given to reducing the amount of paper work 
necessary to initiate a recombinant DNA cloning program with IS. coli K-12 based 
systems and to perform those experiments. It is my impression that currently, for, 
at least, low containment level studies, the bureaucratic process involved in performing 
these experiments may even be more bother than the actual procedures for physical and 
biological containment. Due to our work with R-f actors and "wild" I£. coli , we have 
voluntarily been working at a level approximating that specified as P2. We have 
adjusted to these constraints and I don't consider them to be inhibitory. 
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