CVINGTOU & BURLING 
Donald S. Fredrickson, M.D. 
February 20, 1976 
Page Ten 
will carry, to determine that no experimentation will be under- 
taken in the country in violation of the guidelines. Prolifera- 
tion of experimentation in violation of the guidelines is, in 
short, a legitimate public concern. The concern is not simply 
that a single scientist or his co-workers will be harmed, but 
rather that an accident will result in an epidemic with major 
public harm. Moreover, it is not unlikely that any violation of 
the guidelines would occur not in those institutions which have 
the greatest background and experience in proper experimentation, 
but rather in those institutions where knowledge of this type 
of work, and the hazards it may cause, is only rudimentary. 
I therefore believe that it is imperative for NIH and 
the scientific community immediately to consider various other 
regulatory possibilities for controlling this type of experimen- 
tation by assuring adherence to the guidelines by all segments 
of the scientific community, including those not funded by NIH. 
Various possible regulatory models are, of course, available. 
I am not confident that I presently understand enough about this 
area of scientific endeavor to be able to state with assurance 
at this time exactly which form of regulation would be sufficient 
to assure adherence to the guidelines yet impose only the minimum 
level of regulatory control necessary to achieve the intended 
purpose. I am concerned, however, that if the scientific 
community does not face this issue, it will soon have imposed 
upon it far more stringent and onerous regulatory requirements 
than are necessary and appropriate under the present circumstances. 
The most extreme possibility of regulatory control would 
be a requirement that the Federal government approve every recom- 
binant DNA molecule experiment before it is conducted. I believe 
this type of rigid and complete control is wholly unnecessary, 
and should not be adopted. Far less stringent controls would 
appear to be sufficient to assure public protection. One 
possibility would be to license all laboratories and/or researchers 
conducting this type of experimentation. A second possibility 
would be to license the materials used in these experiments, 
such as the enzyme and the source of the foreign DNA, when they 
are intended for this specific use. Either or both of these 
possibilities could be accomplished without any change in exist- 
ing legislation, under the provisions of Section 361 of the Public 
Health Service Act, 42 U.S.C. 264, which authorizes the Secretary 
of HEW to promulgate regulations necessary to prevent the intro- 
duction or spread of communicable disease. Another possible means 
of regulatory control would be to impose these guidelines on all 
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