Dr. Donald Fredrickson 
October 12, 1976 
Page 5 
1. Increases in the stringency of the guidelines (considered in 
VI.C.l) 
Increasing the stringency of the guidelines will not, by 
itself, provide adequate protection because it will not solve 
the problems which arise specifically from proliferation, namely, 
variations in the behavior of researchers and in the hardware 
they use. As the numbers of laboratories and students trained 
in gene transplantation techniques grow, it will be impossible 
to maintain the same order of control possible in a small number. 
Moreover, the advisability of training large numbers of people 
in a hazardous technique is itself a major policy question which 
should be debated at length in public. 
2. Establishment of national P3 facilities openly available to 
all investigators (considered in VI. C. 2) 
Again, this option does not solve the problems generated by 
proliferation. In the first place, it does not apply to the 
large number of experiments that may be carried out in P2 con- 
tainment. Thus, this option assumes precisely what many biolo- 
gists doubt, namely, the safety of "low-risk" experiments. 
Second, it apparently does not assume any significant cut in 
the number of experiments performed: the fundamental problem of 
control remains. Third, given our present ignorance of the bio- 
logical implications of gene transplantation, P3 may not be suf- 
ficient to contain the hazards. 
3. General federal regulation of gene transplantation (considered 
in VI. E) 
The futility of any policy (including the present one) that 
does not apply uniformly to all institutions which practice gene 
transplantation, both inside and outside the purview of the NIH, 
is self-evident. The present policy, which applies only to 
recipients of NIH funds, means that high school students can 
transplant genes without guidelines while graduate students cannot, 
and industries can use cultures larger than 10 liters whereas 
universities cannot, without special permission. It is hardly 
necessary to point out that microbes will not respect institutional 
differences. The NIH and the U.S. government should follow the 
recommendation of the British Health and Safety Commission that 
guidelines be translated into statutory regulations.^^ 
4. Proposal : all recombinant DNA work to be conducted in a 
national facility^^ 
A number of considerations lead us to believe that in order 
to adequately protect society from the risks entailed by this 
research, it is essential to develop a policy which will be re- 
versible, if necessary, in the light of future experience. Our 
Appendix K — 34 
